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FDA 510(k)

CHEMSTRIP 101 URINE ANALYZER

K-Number: K983510 · 1998-10-27

ApplicantBoehringer Mannheim Corp.
Decision Date1998-10-27
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMSTRIP 101 URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-10-27 under 510(k) number K983510. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMSTRIP 101 URINE ANALYZER?

CHEMSTRIP 101 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 1998-10-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K983510.

When did CHEMSTRIP 101 URINE ANALYZER receive FDA 510(k) clearance?

CHEMSTRIP 101 URINE ANALYZER received FDA 510(k) clearance on 1998-10-27, under 510(k) number K983510.

Who is the listed applicant for CHEMSTRIP 101 URINE ANALYZER?

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

What is the FDA product code for CHEMSTRIP 101 URINE ANALYZER?

The FDA product code for CHEMSTRIP 101 URINE ANALYZER is KQO.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: KQO)

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.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, 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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