The following data is part of a premarket notification filed by Monobind with the FDA for Total Triiodothyronine(t3) Microplate Eia.
Device ID | K971779 |
510k Number | K971779 |
Device Name: | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
Contact | Frederick R Jerome |
Correspondent | Frederick R Jerome MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-14 |
Decision Date | 1997-06-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B24225TRIHUE010 | K971779 | 000 |
00816870021560 | K971779 | 000 |
00816870021553 | K971779 | 000 |
00816870021546 | K971779 | 000 |
00816870021539 | K971779 | 000 |
00840239052759 | K971779 | 000 |
04048474041071 | K971779 | 000 |
04048474052770 | K971779 | 000 |
04048474052756 | K971779 | 000 |