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FDA 510(k)

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

K-Number: K873250 · 1987-10-20

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-10-20
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873250. 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 ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL?

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K873250.

When did ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL receive FDA 510(k) clearance?

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873250.

Who is the listed applicant for ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL?

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

What is the FDA product code for ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL?

The FDA product code for ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL is CIJ.

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Other records listing Roche Diagnostic Systems, 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.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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