The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc Plt-4.
| Device ID | K802265 |
| 510k Number | K802265 |
| Device Name: | CBC PLT-4 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021961 | K802265 | 000 |
| 00815762020339 | K802265 | 000 |
| 00815762020353 | K802265 | 000 |
| 00815762020360 | K802265 | 000 |
| 00815762020377 | K802265 | 000 |
| 00815762020391 | K802265 | 000 |
| 00815762020407 | K802265 | 000 |
| 00815762020414 | K802265 | 000 |
| 00815762020421 | K802265 | 000 |
| 00815762020452 | K802265 | 000 |
| 00815762020469 | K802265 | 000 |
| 00815762021053 | K802265 | 000 |
| 00815762021060 | K802265 | 000 |
| 00815762021077 | K802265 | 000 |
| 00815762021107 | K802265 | 000 |
| 20815762020340 | K802265 | 000 |