The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for Toxoplasma Gondii Serological Reagents.
| Device ID | K803134 |
| 510k Number | K803134 |
| Device Name: | TOXOPLASMA GONDII SEROLOGICAL REAGENTS |
| Classification | Antigens, If, Toxoplasma Gondii |
| Applicant | MICROBIOLOGICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLZ |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-12 |
| Decision Date | 1981-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745013411 | K803134 | 000 |
| 00613745010069 | K803134 | 000 |
| 00613745010250 | K803134 | 000 |
| 00613745012001 | K803134 | 000 |
| 00613745012018 | K803134 | 000 |
| 00613745012025 | K803134 | 000 |
| 00613745012032 | K803134 | 000 |
| 00613745012049 | K803134 | 000 |
| 00613745012056 | K803134 | 000 |
| 00613745012070 | K803134 | 000 |
| 00613745013008 | K803134 | 000 |
| 00613745013091 | K803134 | 000 |
| 00613745010052 | K803134 | 000 |