The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Calibration Verification Assessment (cva).
| Device ID | K960557 |
| 510k Number | K960557 |
| Device Name: | CALIBRATION VERIFICATION ASSESSMENT (CVA) |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Contact | Theodore W Heise |
| Correspondent | Theodore W Heise STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001669 | K960557 | 000 |
| 14987562460387 | K960557 | 000 |
| 14987562460608 | K960557 | 000 |
| 14987562460615 | K960557 | 000 |
| 14987562461780 | K960557 | 000 |
| 14987562461797 | K960557 | 000 |
| 00844509001379 | K960557 | 000 |
| 00844509001386 | K960557 | 000 |
| 00844509001393 | K960557 | 000 |
| 00844509001409 | K960557 | 000 |
| 00844509001416 | K960557 | 000 |
| 00844509001423 | K960557 | 000 |
| 00844509001430 | K960557 | 000 |
| 00844509001447 | K960557 | 000 |
| 00844509001560 | K960557 | 000 |
| 00844509001577 | K960557 | 000 |
| 00844509001584 | K960557 | 000 |
| 00844509001591 | K960557 | 000 |
| 14987562460257 | K960557 | 000 |