The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Beta Hcg Control Level 1 Beta Hcg Control Level 2 Beta Hcg Control Level 3 Beta Hcg Calibration Verification Controls Le.
| Device ID | K121237 |
| 510k Number | K121237 |
| Device Name: | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Contact | Dawn Gast |
| Correspondent | Dawn Gast CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749002573 | K121237 | 000 |
| 00054749002566 | K121237 | 000 |
| 00054749002559 | K121237 | 000 |
| 00054749001040 | K121237 | 000 |