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FDA 510(k)

ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL

K-Number: K882535 · 1988-07-14

ApplicantAbbott Laboratories
Decision Date1988-07-14
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-07-14 under 510(k) number K882535. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL?

ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1988-07-14. The listed applicant is Abbott Laboratories. The 510(k) number is K882535.

When did ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL receive FDA 510(k) clearance?

ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL received FDA 510(k) clearance on 1988-07-14, under 510(k) number K882535.

Who is the listed applicant for ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL?

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) CHLAMYDIA POSITIVE CONTROL?

The FDA product code for ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL is LJC.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.

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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