The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Steroid 21-hydroxylase Antibody (21-ohab) Ria Assay Kit.
| Device ID | K121046 |
| 510k Number | K121046 |
| Device Name: | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT |
| Classification | 21-hydroxylase Antibody (21-ohab) |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S. Seneca Springs Way Suite 105 Star, ID 83669 |
| Contact | Heather Viele |
| Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S. Seneca Springs Way Suite 105 Star, ID 83669 |
| Product Code | PCG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR60150 | K121046 | 000 |
| B126KR60100 | K121046 | 000 |
| 00840239059550 | K121046 | 000 |