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FDA 510(k)

URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2

K-Number: K981933 · 1998-06-29

ApplicantMedical Analysis Systems, Inc.
Decision Date1998-06-29
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981933. 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 URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2?

URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K981933.

When did URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 receive FDA 510(k) clearance?

URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981933.

Who is the listed applicant for URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2?

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

What is the FDA product code for URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2?

The FDA product code for URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 is JJW.

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Other records listing Medical Analysis Systems, Inc. as applicant

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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

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

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