Medical Device Manufacturer · US , Mchenry , IL

Pacific Biotech, Inc. - FDA 510(k) Cleared Devices

29 submissions · 29 cleared · Since 1983

Total

Cleared

Denied

Pacific Biotech, Inc. has 29 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 29 cleared submissions from 1983 to 1993.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Pacific Biotech, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Pacific Biotech, Inc.

29 devices

1-12 of 29

Cleared Dec 02, 1993

STREP A NEGATIVE CONTROL

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT

K896482 · LCX

Chemistry · 113d

Cleared Dec 13, 1989

CARDS O.S.(TM) STREP A

K896221 · GTZ

Microbiology · 44d

Cleared Nov 13, 1989

CARDS O.S. (TM) HCG-URINE

FIRSTDAY EARLY PREGNANCY TESTING KIT II

K884616 · JHI

Chemistry · 70d

Cleared Jan 03, 1989

MODIFIED TSH IRMA KIT

MODIFIED BETA QUIK STAT EIA KIT

K882895 · DHA

Chemistry · 93d

Cleared Oct 06, 1988

MODIFIED HCG IRMA KIT

K883639 · JHI

Chemistry · 42d

Cleared Aug 29, 1988

FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT

K881015 · JHI

Chemistry · 172d

Pacific Biotech, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Pacific Biotech, Inc.

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