Medical Device Manufacturer · US , Van Nuys , CA

Pyramid Biological Corp.

12 submissions · 12 cleared · Since 1993
12
Total
12
Cleared
0
Denied

Pyramid Biological Corp. — FDA 510(k) Submissions

Pyramid Biological Corp. has submitted 12 FDA 510(k) premarket notifications since 1993, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Antiserum, Cf, Cytomegalovirus, Antisera, Cf, Rubella, Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, Antigens, Iha, Toxoplasma Gondii . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
H.PYLORI CONTROLS
K964675 · LYR Helicobacter Pylori · Microbiology
Jan 1997 67d
HEPATITIS NEGATIVE CONTROL
K962399 · MJY Kit, Serological,... · Microbiology
Aug 1996 42d
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · LIP Enzyme Linked... · Microbiology
Jun 1996 80d
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · LIP Enzyme Linked... · Microbiology
Jun 1996 137d
ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
K954515 · GOM Antisera, Cf, Rubella · Microbiology
Dec 1995 83d
ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
K953826 · GOM Antisera, Cf, Rubella · Microbiology
Dec 1995 121d
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
K952818 · GMM Antigens, Iha, Toxoplasma... · Microbiology
Nov 1995 153d
CMV IGG HUMAN SERUM CONTROLS
K951800 · GQI Antiserum, Cf,... · Microbiology
Nov 1995 212d
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · GQI Antiserum, Cf,... · Microbiology
Nov 1995 185d
SERUM PROTEIN CONTROLS
K944515 · JJX Single (specified)... · Chemistry
Nov 1994 63d
REFRACTOMETRIC, TOTAL PROTEIN
K933218 · JJX Single (specified)... · Chemistry
Feb 1994 231d
B-HCG HUMAN SERUM CONTROLS
K932479 · JJX Single (specified)... · Chemistry
Dec 1993 192d
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