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FDA 510(k)

MILES URINE AMYLASE METHOD

K-Number: K923105 · 1992-09-28

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-09-28
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES URINE AMYLASE METHOD 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 1992-09-28 under 510(k) number K923105. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILES URINE AMYLASE METHOD?

MILES URINE AMYLASE METHOD is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K923105.

When did MILES URINE AMYLASE METHOD receive FDA 510(k) clearance?

MILES URINE AMYLASE METHOD received FDA 510(k) clearance on 1992-09-28, under 510(k) number K923105.

Who is the listed applicant for MILES URINE AMYLASE METHOD?

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 MILES URINE AMYLASE METHOD?

The FDA product code for MILES URINE AMYLASE METHOD is JFJ.

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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: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, 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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