Atlas FDA

IQ/QCA PHOSPHORUS

FDA 510(k) clearance K891218 · decided 1989-03-22

Clearance details

K-number
K891218
Device name
IQ/QCA PHOSPHORUS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1989-03-07
Decision date
1989-03-22
Days to decision
15 days
Clearance type
Traditional
Product code
CEO
Device class
1
Regulation number
862.1580
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263)Seppim S.A.S.2011-05-06
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)Beckman Coulter, Inc.2004-08-18
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
PICCOLO PHOSPHORUS TEST SYSTEM (K022312)Abaxis, Inc.2002-09-05
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095)Wiener Laboratories Saic2001-11-16
PHOSPHORUS REAGENT (K003912)Jas Diagnostics, Inc.2001-02-21
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
HICHEM PHOSPHORUS REAGENT KIT (K981769)Elan Pharma, Inc.1998-06-29
CARESIDE ANALYZER (K981610)Careside, Inc.1998-06-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05