The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix Human Serum Therapeutic Drug Control.
| Device ID | K853933 |
| 510k Number | K853933 |
| Device Name: | QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Contact | Lynette Schneider |
| Correspondent | Lynette Schneider QUANTIMETRIX CORP. 4955 WEST 145 ST. Hawthorne, CA 90250 -6703 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-04 |