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FDA 510(k)

BIOTROL ALPHA AMYLASE

K-Number: K872831 · 1987-09-04

ApplicantBiotrol, USA, Inc.
Decision Date1987-09-04
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL ALPHA AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K872831. 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 BIOTROL ALPHA AMYLASE?

BIOTROL ALPHA AMYLASE is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K872831.

When did BIOTROL ALPHA AMYLASE receive FDA 510(k) clearance?

BIOTROL ALPHA AMYLASE received FDA 510(k) clearance on 1987-09-04, under 510(k) number K872831.

Who is the listed applicant for BIOTROL ALPHA AMYLASE?

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

What is the FDA product code for BIOTROL ALPHA AMYLASE?

The FDA product code for BIOTROL ALPHA AMYLASE is CIJ.

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Other records listing Biotrol, USA, 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.

K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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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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