The following data is part of a premarket notification filed by Accumetrics, Inc. with the FDA for Accumetrics,inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest.
| Device ID | K141427 |
| 510k Number | K141427 |
| Device Name: | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST |
| Classification | System, Automated Platelet Aggregation |
| Applicant | ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. SUITE B San Diego, CA 92121 |
| Contact | Frank M Laduca |
| Correspondent | Frank M Laduca ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. SUITE B San Diego, CA 92121 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234150078 | K141427 | 000 |