The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix Serum Enzyme Control.
| Device ID | K880701 |
| 510k Number | K880701 |
| Device Name: | QUANTIMETRIX SERUM ENZYME CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | Johnson, Iii |
| Correspondent | Johnson, Iii QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-03-24 |