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FDA 510(k)

ENZYMATIC ALPHA-AMYLASE REAGENT KIT

K-Number: K860245 · 1986-03-14

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1986-03-14
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC ALPHA-AMYLASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K860245. 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 ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

ENZYMATIC ALPHA-AMYLASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K860245.

When did ENZYMATIC ALPHA-AMYLASE REAGENT KIT receive FDA 510(k) clearance?

ENZYMATIC ALPHA-AMYLASE REAGENT KIT received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860245.

Who is the listed applicant for ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

The FDA product code for ENZYMATIC ALPHA-AMYLASE REAGENT KIT is JFJ.

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Other records listing Bio-Analytics Laboratories, 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860213ALBUMIN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK851513ULTRA-VIOLET BUN REAGENT KITK850639ENZYMATIC ALPHA-AMYLASE REAGENT KITK832771ERYTHROCYTE TEST

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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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