The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Creatinine Reagent, Product No Cr105-01, Creatinine Reagent, Product No Cr105-02.
| Device ID | K991109 |
| 510k Number | K991109 |
| Device Name: | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-05-25 |