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FDA 510(k)

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

K-Number: K853951 · 1986-01-07

ApplicantBehring Diagnostics, Inc.
Decision Date1986-01-07
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-01-07 under 510(k) number K853951. The device is classified under product code CIJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOTRAK AMYLASE TEST AMYLASE ISOENZYME?

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K853951.

When did ISOTRAK AMYLASE TEST AMYLASE ISOENZYME receive FDA 510(k) clearance?

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME received FDA 510(k) clearance on 1986-01-07, under 510(k) number K853951.

Who is the listed applicant for ISOTRAK AMYLASE TEST AMYLASE ISOENZYME?

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

What is the FDA product code for ISOTRAK AMYLASE TEST AMYLASE ISOENZYME?

The FDA product code for ISOTRAK AMYLASE TEST AMYLASE ISOENZYME is CIJ.

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Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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Related Devices (Code: CIJ)

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.

K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, 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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