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FDA 510(k)

ABBOTT TESTPACK (TM) HCG SERUM

K-Number: K863032 · 1986-09-15

ApplicantAbbott Laboratories
Decision Date1986-09-15
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK (TM) HCG SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K863032. 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 ABBOTT TESTPACK (TM) HCG SERUM?

ABBOTT TESTPACK (TM) HCG SERUM is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Abbott Laboratories. The 510(k) number is K863032.

When did ABBOTT TESTPACK (TM) HCG SERUM receive FDA 510(k) clearance?

ABBOTT TESTPACK (TM) HCG SERUM received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863032.

Who is the listed applicant for ABBOTT TESTPACK (TM) HCG SERUM?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBOTT TESTPACK (TM) HCG SERUM?

The FDA product code for ABBOTT TESTPACK (TM) HCG SERUM is JHI.

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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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