The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Thyroid Stimulating Hormone (htsh) Irma Neonatal.
| Device ID | K883726 |
| 510k Number | K883726 |
| Device Name: | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Contact | J Burns |
| Correspondent | J Burns IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-31 |
| Decision Date | 1988-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022382 | K883726 | 000 |