The following data is part of a premarket notification filed by Monobind with the FDA for Follicle Stimulating Hormone (fsh) Microplate Elisa (425-300).
Device ID | K972720 |
510k Number | K972720 |
Device Name: | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
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 | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-21 |
Decision Date | 1997-09-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816870020914 | K972720 | 000 |
00816870020907 | K972720 | 000 |
00840239040985 | K972720 | 000 |
04048474040982 | K972720 | 000 |