The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Oveia (tm) Dual Analyte.
| Device ID | K872843 |
| 510k Number | K872843 |
| Device Name: | OVEIA (TM) DUAL ANALYTE |
| Classification | Spectrophotometric Method, Pregnanediol |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | John G Simpson |
| Correspondent | John G Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | JLP |
| CFR Regulation Number | 862.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-20 |
| Decision Date | 1988-02-02 |