The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Bilirubin, Total And Direct, Product No, 122-01, 122-02, 122-03, 122-04.
| Device ID | K991866 |
| 510k Number | K991866 |
| Device Name: | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-08-02 |