The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Albumin Bcg, Model Al 103-01.
| Device ID | K990978 |
| 510k Number | K990978 |
| Device Name: | ALBUMIN BCG, MODEL AL 103-01 |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| 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 | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 1999-05-25 |