The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Albumin Bcp.
| Device ID | K844426 |
| 510k Number | K844426 |
| Device Name: | ALBUMIN BCP |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Sue Smith |
| Correspondent | Sue Smith BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-15 |
| Decision Date | 1985-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630990634 | K844426 | 000 |
| 04015630928064 | K844426 | 000 |