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FDA 510(k)

HEMASTIX REAGENT STRIPS

K-Number: K905396 · 1991-02-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-02-11
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMASTIX REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905396. The device is classified under product code JIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMASTIX REAGENT STRIPS?

HEMASTIX REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K905396.

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

HEMASTIX REAGENT STRIPS received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905396.

Who is the listed applicant for HEMASTIX REAGENT STRIPS?

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

What is the FDA product code for HEMASTIX REAGENT STRIPS?

The FDA product code for HEMASTIX REAGENT STRIPS is JIO.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: JIO)

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.

K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd.K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLCK111221MISSION U500 URINE ANALYZERACON Laboratories, Inc.K082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERSUrit Medical Electronic Co., Ltd.K083724WIENER LAB. URINE STRIP 10 AND 11Wiener Laboratorios SaicK040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISDirui Industrial 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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