ALBUMIN BCP
FDA 510(k) clearance K844426 · decided 1985-01-07
Clearance details
- K-number
- K844426
- Device name
- ALBUMIN BCP
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-15
- Decision date
- 1985-01-07
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- CJW
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boehringer Mannheim Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Albumin BCP2 (K203530) | Abbott Ireland Diagnostics Division | 2022-03-18 |
| Albumin BCP (K193001) | SENTINEL CH. SpA | 2019-12-19 |
| ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR (K132664) | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| ALBUMIN REAGENT (K021636) | Intersect Systems, Inc. | 2002-07-17 |
| RANDOX ALBUMIN (K000483) | Randox Laboratories, Ltd. | 2000-03-31 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBP (K981814) | Abbott Laboratories | 1998-07-22 |
| ALBP (K981457) | Abbott Mfg., Inc. | 1998-05-27 |
| ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| ALBUMIN REAGENT SET (K905776) | Biochemical Trade, Inc. | 1991-02-26 |
| ALBUMIN (BCP) (K863226) | Sigma Diagnostics, Inc. | 1986-09-17 |
| EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004) | Em Diagnostic Systems, Inc. | 1986-09-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |