Atlas FDA

CHJ

53 FDA 510(k) clearances · Product code

52 daysmedian time to decision
111 days90th percentile
53clearances measured

FDA profile

Official device name
Mercuric Thiocyanate, Colorimetry, Chloride
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1170
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
PICCOLO CHLORIDE TEST SYSTEM (K010670)Abaxis, Inc.2001-04-26
340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (K945408)Catachem, Inc.1995-02-22
CHLORIDE QVET (K943006)Prisma Systems1994-12-07
OLYMPUS CHLORIDE REAGENT, MODIFICATION (K934136)Olympus Corp.1993-11-05
OLYMPUS CHLORID REAGENT, MODIFIED (K932528)Olympus Corp.1993-09-17
OLYMPUS CHLORIDE REAGENT (K925338)Olympus Corp.1992-12-11
KING DIAGNOSTICS CHLORIDE REAGENT (K922921)King Diagnostics, Inc.1992-10-05
OLYMPUS CHLORIDE REAGENT (K923610)Olympus Corp.1992-10-02
URINE CHLORIDE (K923036)Heraeus Kulzer, Inc.1992-09-09
CHLORIDE REAGENT (K911297)Intersect Systems, Inc.1991-04-16
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED (K910133)Olympus Corp.1991-02-27
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. (K901500)Olympus Corp.1990-07-10
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES (K892929)Technicon Instruments Corp.1989-07-20
BIOTROL CHLORIDE (K890015)Biotrol, USA, Inc.1989-02-17
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE (K884601)Technicon Instruments Corp.1989-01-27
CHLORIDE TEST (CL) ITEM #65659 (K884706)Em Diagnostic Systems, Inc.1989-01-11
ROCHE REAGENT FOR CHLORIDE (K884013)Roche Diagnostic Systems, Inc.1988-12-09
CHLORIDE (K883386)Tech-Co, Inc.1988-10-06
CHLORIDE LIQUID STABLE REAGENT SET (K881200)Medical Analysis Systems, Inc.1988-04-28
CHLORIDE REAGENT SET (K881240)Tech-Neal Scientific, Inc.1988-04-28
CHLORIDE CAT. # 152-17 (K875208)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
MULTICHEM CHLORIDE REAGENT S0933 (K874812)Simmler, Inc.1987-12-18
CHLORIDE REAGENT - THIOCYANATE METHOD (K870367)Trace Scientific , Ltd.1987-08-21
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS (K872511)Catachem, Inc.1987-07-21
CHLORIDE TEST (K870630)Sclavo, Inc.1987-04-22
CHLORIDE REAGENT (K864713)Sigma Diagnostics, Inc.1986-12-31
CHLORIDE PROCEDURE (K863585)Data Medical Associates, Inc.1986-10-16
RAICHEM(TM) CHLORIDE REAGENT (K863620)Reagents Applications, Inc.1986-09-26
CLOROFAST (K863061)J. D. Assoc.1986-09-09
CHLORIDE PROCEDURE (K861674)Data Medical Associates, Inc.1986-07-01
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271 (K860662)Amresco, Inc.1986-03-14
CHLORIDE REAGENT (K852169)Pointe Scientific, Inc.,1985-08-21
CHLORIDE ASSAY KIT (K852058)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
CHLORIDE (K850935)Dilab, Inc.1985-06-10
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS (K850334)Roche Diagnostic Systems, Inc.1985-03-14
SCLAVO CHLORIDE TEST (K843740)Sclavo, Inc.1984-10-05
CHLORIDE TEST KIT (K842011)Mallinckrodt Critical Care1984-06-22
PARAMAX CHLORIDE REAGENT (K841047)American Dade1984-04-19
FLOW-PAC CHLORIDE REAGENT SET (K834333)American Research Products Co.1984-02-21
CHLORIDE REAGENT SET (K832438)Amresco, Inc.1984-01-20
TECH. RA-1000 SYS SERUM CHLORIDE (K833746)Technicon Instruments Corp.1984-01-13
PROCEDURE 460 FOR DETERM. OF CHLORIDE (K833166)Sigma Chemical Co.1983-10-28
TPTZ CHLORIDE (K820235)American Monitor Corp.1982-02-12
CHLORIDE/TCO2 ANALYZER REAGENTS (K803013)Laboratory Products, Inc.1981-01-02
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT (K802163)Panmed, Inc.1980-10-10
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM (K800683)Diagnostic Solutions, Inc.1980-05-28
CHLORIDE REAGENT (K792605)Gilford Diagnostics1980-01-16
SANDARE CHLORIDE PROCEDURE (K792531)Sandare Chemical Co., Inc.1980-01-11
ELVI CHLORIDE (K792400)Volu Sol Medical Industries1979-12-07
CHLORIDE REAGENT (K781460)Analytical & Research Chemicals, Inc.1978-10-10
CHLORIDE TEST SET, CAT.# 0210 (K781635)Stanbio Laboratory1978-10-03
REAGENT, CHLORIDE, COULTER (K770752)Coulter Electronics, Inc.1977-06-17
CHLORIDE PROCEDURE, TEKPOINT DIRECT (K770450)Icn Pharmaceuticals, Inc.1977-05-03

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Every clearance here is in the API, with alerts when new ones post.