Abbott Laboratories - FDA 510(k) Cleared Devices
882
Total
867
Cleared
0
Denied
347 devices
Cleared
Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
Chemistry
25d
Cleared
Jun 24, 1997
ABBOTT AXSYM FOLATE
Chemistry
8d
Cleared
Mar 24, 1997
AXSYM B12
Chemistry
90d
Cleared
Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
Chemistry
20d
Cleared
Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
Chemistry
62d
Cleared
Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
Chemistry
15d
Cleared
Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
Chemistry
36d
Cleared
Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
Chemistry
36d
Cleared
Mar 07, 1996
AXSYM PROGESTERONE
Chemistry
126d
Cleared
Oct 05, 1995
TESTPACK PLUS HCG URINE
Chemistry
38d
Cleared
Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
Chemistry
52d
Cleared
Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
Chemistry
231d
Cleared
May 17, 1995
IMX ESTRADIOL
Chemistry
61d
Cleared
Feb 08, 1995
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
Chemistry
351d
Cleared
Nov 14, 1994
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
Chemistry
95d
Cleared
Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
Chemistry
77d
Cleared
Jun 21, 1994
AXSYM(TM) T-UPTAKE
Chemistry
293d
Cleared
Jun 21, 1994
AXSYM(TM) TOTAL T4
Chemistry
293d
Cleared
Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
Chemistry
284d
Cleared
Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
Chemistry
272d
Cleared
Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
Chemistry
211d
Cleared
Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
Chemistry
211d
Cleared
Jun 21, 1994
AXSYM TOTAL B-HCG
Chemistry
207d
Cleared
Jun 21, 1994
AXSYM PROLACTIN
Chemistry
207d
Cleared
Jun 21, 1994
AXSYM CK-MB
Chemistry
190d
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