Atlas FDA

JIW

17 FDA 510(k) clearances · Product code

59 daysmedian time to decision
126 days90th percentile
17clearances measured

FDA profile

Official device name
Calibrator, Surrogate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Medical specialty
Clinical Chemistry
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RecordFirmDate
WAKO CH50 LINEARITY SET (K973055)Wako Chemicals USA, Inc.1997-09-25
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (K970396)Dade Chemistry Systems, Inc.1997-02-20
FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255)Sigma Diagnostics, Inc.1991-04-03
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (K902575)Diagnostic Products Corp.1990-10-04
ACCUSCAN MICROBEAD STANDARDS (K902294)Sigma Chemical Co.1990-07-03
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (K892213)Analytical Control Systems, Inc.1989-06-21
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (K883389)Reagents Applications, Inc.1988-12-14
CALIBRATION KIT (K882220)King Diagnostics, Inc.1988-08-02
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (K880654)American Research Products Co.1988-06-07
UNIMETER CALIBRATION KIT (K880610)Boehringer Mannheim Corp.1988-03-24
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (K854028)Verified Medical Research, Inc.1985-12-02
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450)Flow Cytometry Standards Corp.1985-09-16
QUICK-CHEM CALIBRATION SET (K852260)Seragen Diagnostics, Inc.1985-07-22
NEPHELOMETRIC SOLID TURBIDITY STANDARD (K812220)Hyland Therapeutic Div., Travenol Laboratories1981-08-18
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) (K801300)E.I. Dupont DE Nemours & Co., Inc.1980-07-08
CENTRIFICHEM FILTER CALIBRATION SET (K800304)Union Carbide Corp.1980-03-12
CENTRIFICHEM FILTER CALIBRATION SET (K790643)Union Carbide Corp.1979-05-23

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