510(k) K000483
- Device
- RANDOX ALBUMIN
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K000483
- Product code
- CJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-31
- Date received
- 2000-02-14
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- P ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin, Co. Antrim IE BT29 4QY BT29 4QY
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#
510(k) summary PDF not indicated by FDA
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 |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K981814 | ALBP | Abbott Laboratories | 1998-07-22 |
| 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#
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FDA Review#
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