The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Capra (caprac-r) Wipetest And Well Counter.
| Device ID | K946387 |
| 510k Number | K946387 |
| Device Name: | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Mary A Dell |
| Correspondent | Mary A Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1995-03-30 |