Submission Details
| 510(k) Number | K971503 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 1997 |
| Decision Date | August 20, 1997 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
MYCOPLASMA IGM ELISA TEST SYSTEM
Aug 1997
Decision
118d
Days
Class 1
Risk
About This 510(k) Submission
K971503 is an FDA 510(k) clearance for the MYCOPLASMA IGM ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 20, 1997, 118 days after receiving the submission on April 24, 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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