The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 4 Plus.
| Device ID | K933844 |
| 510k Number | K933844 |
| Device Name: | PARA 4 PLUS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Hal Sornson |
| Correspondent | Hal Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1993-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001737 | K933844 | 000 |
| 00844509001720 | K933844 | 000 |
| 00844509001713 | K933844 | 000 |
| 00844509001706 | K933844 | 000 |
| 20844509001694 | K933844 | 000 |
| 20844509001687 | K933844 | 000 |
| 20844509001670 | K933844 | 000 |