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FDA 510(k)

TESTPACK ACUTE HCG URINGE CONTROLS

K-Number: K863127 · 1986-09-15

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

Device Summary

TESTPACK ACUTE HCG URINGE CONTROLS 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 K863127. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTPACK ACUTE HCG URINGE CONTROLS?

TESTPACK ACUTE HCG URINGE CONTROLS 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 K863127.

When did TESTPACK ACUTE HCG URINGE CONTROLS receive FDA 510(k) clearance?

TESTPACK ACUTE HCG URINGE CONTROLS received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863127.

Who is the listed applicant for TESTPACK ACUTE HCG URINGE CONTROLS?

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 TESTPACK ACUTE HCG URINGE CONTROLS?

The FDA product code for TESTPACK ACUTE HCG URINGE CONTROLS is JJW.

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Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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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