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