Atlas FDA

LER

15 FDA 510(k) clearances · Product code

41 daysmedian time to decision
85 days90th percentile
15clearances measured

FDA profile

Official device name
Fluorescent Immunoassay, Theophylline
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3880
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192)Sigma Diagnostics, Inc.1994-07-13
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (K905521)Microgenics Corp.1990-12-26
TURBOX THEOPHYLLINE ASSAY (K882570)Unipath , Ltd.1988-11-10
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (K864409)Sclavo, Inc.1986-12-22
THEOFAST(TM) TEST PACKAGE (K863475)3M Company1986-11-05
THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (K842585)Windsor Laboratories, Inc.1984-09-26
IMMPULSE THEOPHYLLINE ASSAY REAGENTS (K840758)Paragon Diagnostics, Inc.1984-04-04
TDX THEOPHYLLINE (K833070)Abbott Laboratories1983-11-14
AMWA TDA THEOPHYLLINE TEST (K831514)Miles Laboratories, Inc.1983-06-30
COBAS STANDARD FOR TOTAL PROTEIN (K823576)Hoffmann-La Roche, Inc.1983-01-07
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (K820397)American Diagnostic Corp.1982-03-02
EMIT-AAD THEOPHYLLINE ASSAY (K813240)Syva Co.1981-12-03
AMES TDA THEOPHYLLINE TEST (K812518)Miles Laboratories, Inc.1981-09-23
FLUOROMATIC THEOPHYLLINE FIA (K811856)Bio-Rad1981-07-10
AMES TDA THEOPHYLLINE TEST (K810943)Miles Laboratories, Inc.1981-04-17

Track LER automatically

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