Submission Details
| 510(k) Number | K970150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1997 |
| Decision Date | June 16, 1997 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
MYCOPLASMA IGG ELISA TEST SYSTEM
Jun 1997
Decision
152d
Days
Class 1
Risk
About This 510(k) Submission
K970150 is an FDA 510(k) clearance for the MYCOPLASMA IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 16, 1997, 152 days after receiving the submission on January 15, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.
Device Classification
| Product Code | LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3375 |
Manufacturer
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