The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Neonatal Tsh (125i) Immunoradiometric Assay.
| Device ID | K912324 |
| 510k Number | K912324 |
| Device Name: | NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239014832 | K912324 | 000 |