The following data is part of a premarket notification filed by Quantimetrix Medical Industries with the FDA for Alkphor(tm) System, Human Serum Alka Phos Isoenzy.
| Device ID | K883395 |
| 510k Number | K883395 |
| Device Name: | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | S Johnson,iii |
| Correspondent | S Johnson,iii QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1988-09-19 |