The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex + Rbc.
| Device ID | K960894 |
| 510k Number | K960894 |
| Device Name: | CD-CHEX + RBC |
| Classification | Control, White-cell |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Theodore W Heise |
| Correspondent | Theodore W Heise STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-05 |
| Decision Date | 1996-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000174 | K960894 | 000 |
| 20844509000093 | K960894 | 000 |
| 20844509000130 | K960894 | 000 |
| 20844509000147 | K960894 | 000 |
| 30844509000083 | K960894 | 000 |
| 30844509000090 | K960894 | 000 |
| 30844509000137 | K960894 | 000 |
| 30844509000144 | K960894 | 000 |
| 40844509000080 | K960894 | 000 |
| 40844509000134 | K960894 | 000 |
| 40844509000141 | K960894 | 000 |
| 00844509000105 | K960894 | 000 |
| 00844509000112 | K960894 | 000 |
| 00844509000129 | K960894 | 000 |
| 00844509000150 | K960894 | 000 |
| 00844509000167 | K960894 | 000 |
| 20844509000086 | K960894 | 000 |