510(k) K981814
- Device
- ALBP
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K981814
- Product code
- CJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-22
- Date received
- 1998-05-22
- Regulation
- 862.1035
- Classification name
- Bromcresol Purple Dye-binding, Albumin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK LITTLEFIELD
- Address
- Dept. 09va Lc-2 1920 Hurd Dr. Irving TX US 75038 75038
FDA Registration Numbers#
- 3005094123
- 3006198300
- 3003795116
- 2030861
- 1181121
- 2050012
- 9680746
- 3005333358
- 2432235
- 9610529
- 1317202
- 3002809144
- 2517506
- 3011989923
- 2939693
- 3016438761
- 2050010
- 3010825766
- 8020888
- 9681753
- 1219913
- 9610126
- 3021841051
Source Documents#
Other 510(k) Records For Product Code CJW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | 2022-03-18 |
| K193001 | Albumin BCP | SENTINEL CH. SpA | 2019-12-19 |
| K132664 | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| K021636 | ALBUMIN REAGENT | Intersect Systems, Inc. | 2002-07-17 |
| K000483 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | 2000-03-31 |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K981457 | ALBP | Abbott Mfg., Inc. | 1998-05-27 |
| K913025 | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | Em Diagnostic Systems, Inc. | 1991-10-09 |
| K905776 | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-26 |
| K863226 | ALBUMIN (BCP) | Sigma Diagnostics, Inc. | 1986-09-17 |
| K863004 | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | Em Diagnostic Systems, Inc. | 1986-09-16 |
| K862138 | VISION ALBUMIN | Abbott Laboratories | 1986-06-17 |
| K860423 | A-GENT LIQUID ALBUMIN | Abbott Laboratories | 1986-03-17 |
| K844426 | ALBUMIN BCP | Boehringer Mannheim Corp. | 1985-01-07 |
| K842847 | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | Wako Chemicals USA, Inc. | 1984-12-11 |
Legacy Summary#
summary
FDA Review#
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