The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para Tech For Technicon H-1.
| Device ID | K896154 |
| 510k Number | K896154 |
| Device Name: | PARA TECH FOR TECHNICON H-1 |
| 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 | 1989-10-24 |
| Decision Date | 1989-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414224404 | K896154 | 000 |
| 00630414224381 | K896154 | 000 |
| 00630414224367 | K896154 | 000 |