The following data is part of a premarket notification filed by Monobind with the FDA for Prolactin (prl) Hormone Microplate Elisa.
| Device ID | K971921 |
| 510k Number | K971921 |
| Device Name: | PROLACTIN (PRL) HORMONE MICROPLATE ELISA |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Contact | Drederick R Jerome |
| Correspondent | Drederick R Jerome MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816870021034 | K971921 | 000 |
| 00816870021027 | K971921 | 000 |