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FDA 510(k)

DADE COLORIMETRIC AMYLASE

K-Number: K813529 · 1981-12-31

ApplicantAmerican Dade
Decision Date1981-12-31
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE COLORIMETRIC AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813529. 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 DADE COLORIMETRIC AMYLASE?

DADE COLORIMETRIC AMYLASE is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is American Dade. The 510(k) number is K813529.

When did DADE COLORIMETRIC AMYLASE receive FDA 510(k) clearance?

DADE COLORIMETRIC AMYLASE received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813529.

Who is the listed applicant for DADE COLORIMETRIC AMYLASE?

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

What is the FDA product code for DADE COLORIMETRIC AMYLASE?

The FDA product code for DADE COLORIMETRIC AMYLASE is CIJ.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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