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FDA 510(k)

CARDS(TM) HCG-URINE

K-Number: K863199 · 1986-09-15

ApplicantPacific Biotech, Inc.
Decision Date1986-09-15
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDS(TM) HCG-URINE is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K863199. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDS(TM) HCG-URINE?

CARDS(TM) HCG-URINE is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K863199.

When did CARDS(TM) HCG-URINE receive FDA 510(k) clearance?

CARDS(TM) HCG-URINE received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863199.

Who is the listed applicant for CARDS(TM) HCG-URINE?

The FDA 510(k) record lists Pacific Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDS(TM) HCG-URINE?

The FDA product code for CARDS(TM) HCG-URINE is JHI.

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Other records listing Pacific Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K924461STREP A NEGATIVE CONTROLK902510CARDS O.S. MONOK896482PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KITK896221CARDS O.S.(TM) STREP AK895390CARDS O.S. (TM) HCG-URINEK891770HCG IRMA II

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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