The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Gsp Instrument And Gsp Neonatal Htsh Kit.
| Device ID | K090846 |
| 510k Number | K090846 |
| Device Name: | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147312009 | K090846 | 000 |
| 06438147311040 | K090846 | 000 |