The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Buffer Chromogen (r1), Product No. Ca110-01, Edta Reagen (r2), Product No. Ca110-02.
| Device ID | K991111 |
| 510k Number | K991111 |
| Device Name: | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 |
| Classification | Cresolphthalein Complexone, Calcium |
| 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 | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-05-25 |