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FDA 510(k)

DART AMYLASE-D.S. REAGENT SYSTEM

K-Number: K862370 · 1986-08-01

ApplicantCoulter Electronics, Inc.
Decision Date1986-08-01
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DART AMYLASE-D.S. REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862370. 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 DART AMYLASE-D.S. REAGENT SYSTEM?

DART AMYLASE-D.S. REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K862370.

When did DART AMYLASE-D.S. REAGENT SYSTEM receive FDA 510(k) clearance?

DART AMYLASE-D.S. REAGENT SYSTEM received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862370.

Who is the listed applicant for DART AMYLASE-D.S. REAGENT SYSTEM?

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

What is the FDA product code for DART AMYLASE-D.S. REAGENT SYSTEM?

The FDA product code for DART AMYLASE-D.S. REAGENT SYSTEM is CIJ.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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