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FDA 510(k)

EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95

K-Number: K860935 · 1986-05-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-05-23
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K860935. 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 EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95?

EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K860935.

When did EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 receive FDA 510(k) clearance?

EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 received FDA 510(k) clearance on 1986-05-23, under 510(k) number K860935.

Who is the listed applicant for EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95?

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

What is the FDA product code for EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95?

The FDA product code for EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 is CIJ.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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