The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para Tech Plus Retics.
| Device ID | K993825 |
| 510k Number | K993825 |
| Device Name: | PARA TECH PLUS RETICS |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Contact | Paul Kittelson |
| Correspondent | Paul Kittelson STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 1999-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414473413 | K993825 | 000 |
| 00630414473406 | K993825 | 000 |
| 00630414473390 | K993825 | 000 |