Submission Details
| 510(k) Number | K993033 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 1999 |
| Decision Date | December 16, 1999 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
INTRAY GC
Dec 1999
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K993033 is an FDA 510(k) clearance for the INTRAY GC, a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY), submitted by Biomed Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on December 16, 1999, 98 days after receiving the submission on September 9, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.
Device Classification
| Product Code | JTY — Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.2410 |
Manufacturer
Similar Devices — JTY Culture Media, For Isolation Of Pathogenic Neisseria
All 82
K210511 · Biomed Diagnostics Incorporated
· Oct 2021
K954986 · Remel, L.P.
· Feb 1996
K950196 · Bioclinical Systems, Inc.
· Jun 1995
K933122 · Bioclinical Systems, Inc.
· Feb 1994
K933121 · Bioclinical Systems, Inc.
· Feb 1994
K934331 · Hardy Diagnostics
· Dec 1993