The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for College Of Amer Path (cap) Surv Valid Prost Spec Anti.
| Device ID | K942647 |
| 510k Number | K942647 |
| Device Name: | COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Contact | Thomas Cantor |
| Correspondent | Thomas Cantor SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1995-07-12 |