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FDA 510(k)

BIOSCAN REAGENT STRIPS

K-Number: K940043 · 1994-04-12

ApplicantBioscan Instruments, Inc.
Decision Date1994-04-12
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSCAN REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Bioscan Instruments, Inc.. It received FDA 510(k) clearance on 1994-04-12 under 510(k) number K940043. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCAN REAGENT STRIPS?

BIOSCAN REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1994-04-12. The listed applicant is Bioscan Instruments, Inc.. The 510(k) number is K940043.

When did BIOSCAN REAGENT STRIPS receive FDA 510(k) clearance?

BIOSCAN REAGENT STRIPS received FDA 510(k) clearance on 1994-04-12, under 510(k) number K940043.

Who is the listed applicant for BIOSCAN REAGENT STRIPS?

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

What is the FDA product code for BIOSCAN REAGENT STRIPS?

The FDA product code for BIOSCAN REAGENT STRIPS is JIL.

Related Clinical Trials

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.

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Other records listing Bioscan Instruments, Inc. 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.

K875248BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS

Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI 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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