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FDA 510(k)

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

K-Number: K951494 · 1995-12-11

ApplicantEmd Chemicals, Inc.
Decision Date1995-12-11
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K951494. 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 AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)?

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K951494.

When did AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) receive FDA 510(k) clearance?

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) received FDA 510(k) clearance on 1995-12-11, under 510(k) number K951494.

Who is the listed applicant for AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)?

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

What is the FDA product code for AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)?

The FDA product code for AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) is CIJ.

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Other records listing Emd Chemicals, Inc. as applicant

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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.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,K940010DMA AMYLASE (DEMAND) PROCEDUREData Medical Associates, 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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