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FDA 510(k)

-AMYLASE EPS

K-Number: K882225 · 1989-01-03

ApplicantBoehringer Mannheim Corp.
Decision Date1989-01-03
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

-AMYLASE EPS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1989-01-03 under 510(k) number K882225. 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 EPS?

-AMYLASE EPS is a medical device that received FDA 510(k) clearance on 1989-01-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K882225.

When did -AMYLASE EPS receive FDA 510(k) clearance?

-AMYLASE EPS received FDA 510(k) clearance on 1989-01-03, under 510(k) number K882225.

Who is the listed applicant for -AMYLASE EPS?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for -AMYLASE EPS?

The FDA product code for -AMYLASE EPS is CIJ.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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