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FDA 510(k)

COAT-A-COUNT INSULIN KIT

K-Number: K821861 · 1982-07-08

ApplicantDiagnostic Products Corp.
Decision Date1982-07-08
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT INSULIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K821861. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT INSULIN KIT?

COAT-A-COUNT INSULIN KIT is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K821861.

When did COAT-A-COUNT INSULIN KIT receive FDA 510(k) clearance?

COAT-A-COUNT INSULIN KIT received FDA 510(k) clearance on 1982-07-08, under 510(k) number K821861.

Who is the listed applicant for COAT-A-COUNT INSULIN KIT?

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

What is the FDA product code for COAT-A-COUNT INSULIN KIT?

The FDA product code for COAT-A-COUNT INSULIN KIT is CFP.

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Other records listing Diagnostic Products 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.

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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