The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 12 Plus.
| Device ID | K901875 |
| 510k Number | K901875 |
| Device Name: | PARA 12 PLUS |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Halvor Sornson |
| Correspondent | Halvor Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-26 |
| Decision Date | 1990-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740017118 | K901875 | 000 |
| 00380740017101 | K901875 | 000 |
| 00844509000235 | K901875 | 000 |
| 00844509000228 | K901875 | 000 |
| 00844509000211 | K901875 | 000 |
| 20844509000208 | K901875 | 000 |
| 20844509000192 | K901875 | 000 |
| 20844509000185 | K901875 | 000 |
| 30844509000199 | K901875 | 000 |