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FDA 510(k)

FREE & TOTAL ESTRIOL KIT

K-Number: K823202 · 1982-12-15

ApplicantDiagnostic Products Corp.
Decision Date1982-12-15
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE & TOTAL ESTRIOL 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 1982-12-15 under 510(k) number K823202. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREE & TOTAL ESTRIOL KIT?

FREE & TOTAL ESTRIOL KIT is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K823202.

When did FREE & TOTAL ESTRIOL KIT receive FDA 510(k) clearance?

FREE & TOTAL ESTRIOL KIT received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823202.

Who is the listed applicant for FREE & TOTAL ESTRIOL 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 FREE & TOTAL ESTRIOL KIT?

The FDA product code for FREE & TOTAL ESTRIOL KIT is CGI.

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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: CGI)

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.

K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company

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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