Pacific Biotech, Inc. - FDA 510(k) Cleared Devices
29
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pacific Biotech, Inc. Chemistry ✕
23 devices
Cleared
Mar 06, 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
Chemistry
113d
Cleared
Nov 13, 1989
CARDS O.S. (TM) HCG-URINE
Chemistry
75d
Cleared
May 24, 1989
HCG IRMA II
Chemistry
61d
Cleared
Jan 13, 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
Chemistry
70d
Cleared
Jan 03, 1989
MODIFIED TSH IRMA KIT
Chemistry
124d
Cleared
Oct 12, 1988
MODIFIED BETA QUIK STAT EIA KIT
Chemistry
93d
Cleared
Oct 06, 1988
MODIFIED HCG IRMA KIT
Chemistry
42d
Cleared
Aug 29, 1988
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
Chemistry
172d
Cleared
Nov 23, 1987
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
Chemistry
67d
Cleared
Jan 14, 1987
CARDS(TM) - EARLY PREGNANCY TEST
Chemistry
139d
Cleared
Sep 15, 1986
CARDS(TM) HCG-URINE
Chemistry
27d
Cleared
Jul 01, 1986
HCG IRMA, CAT. NO. CR-1501
Chemistry
35d
Cleared
Jun 27, 1986
TSH IRMA KIT
Chemistry
15d
Cleared
May 02, 1986
DIRECTACLONE CG SLIDE PREGNANCY TEST
Chemistry
51d
Cleared
Apr 24, 1986
BETA QUIK STICK
Chemistry
42d
Cleared
Aug 20, 1985
BETA QUIK STAT
Chemistry
82d
Cleared
Mar 01, 1985
PRL QUIK RIA KIT
Chemistry
28d
Cleared
Oct 30, 1984
BETA QUIK V
Chemistry
33d
Cleared
Oct 02, 1984
TSH QUIK RIA KIT
Chemistry
22d
Cleared
Mar 23, 1984
FSH QUIK RIA KIT
Chemistry
63d
Cleared
Mar 19, 1984
LH QUIK RIA KIT
Chemistry
62d
Cleared
Jun 08, 1983
PBI BHCG RIA KIT
Chemistry
48d
Cleared
Jun 02, 1983
BETA-QUIK-15 RIA KIT
Chemistry
48d