Submission Details
| 510(k) Number | K924882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 1992 |
| Decision Date | March 23, 1993 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
TOXOPLASMA IGM IFA TEST SYSTEM
Mar 1993
Decision
176d
Days
Class 2
Risk
About This 510(k) Submission
K924882 is an FDA 510(k) clearance for the TOXOPLASMA IGM IFA TEST SYSTEM, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 23, 1993, 176 days after receiving the submission on September 28, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.
Device Classification
| Product Code | GLZ — Antigens, If, Toxoplasma Gondii |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3780 |
Manufacturer
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