CARDS O.S. MONO— 510(k) K902510

Substantially Equivalent

Pacific Biotech, Inc.

FDA 510(k) clearance K902510 for CARDS O.S. MONO, Substantially Equivalent on 1990-07-16. Applicant: Pacific Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Pacific Biotech, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1990-06-05
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTN

K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test2018-06-22
K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)2005-02-28
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K012901 — COLOR-MONOGEN2001-09-27
K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT1999-01-28

More clearances from Pacific Biotech, Inc.

K924461 — STREP A NEGATIVE CONTROL1993-12-02
K896482 — PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT1990-03-06
K896221 — CARDS O.S.(TM) STREP A1989-12-13
K895390 — CARDS O.S. (TM) HCG-URINE1989-11-13
K891770 — HCG IRMA II1989-05-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.