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FDA 510(k)

DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS

K-Number: K933682 · 1994-04-12

ApplicantMiles, Inc.
Decision Date1994-04-12
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Miles, Inc.. It received FDA 510(k) clearance on 1994-04-12 under 510(k) number K933682. 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 DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS?

DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-04-12. The listed applicant is Miles, Inc.. The 510(k) number is K933682.

When did DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS receive FDA 510(k) clearance?

DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS received FDA 510(k) clearance on 1994-04-12, under 510(k) number K933682.

Who is the listed applicant for DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS?

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

What is the FDA product code for DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS?

The FDA product code for DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS is JFJ.

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Other records listing Miles, 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.

K950292FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEMK950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK945655CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)K943376OPERA SYSTEM

View all 11 devices →

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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