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FDA 510(k)

SERAGAN ACTH125 I-RIA KIT

K-Number: K822115 · 1982-10-18

ApplicantSeragen Diagnostics, Inc.
Decision Date1982-10-18
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERAGAN ACTH125 I-RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822115. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAGAN ACTH125 I-RIA KIT?

SERAGAN ACTH125 I-RIA KIT is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K822115.

When did SERAGAN ACTH125 I-RIA KIT receive FDA 510(k) clearance?

SERAGAN ACTH125 I-RIA KIT received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822115.

Who is the listed applicant for SERAGAN ACTH125 I-RIA KIT?

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

What is the FDA product code for SERAGAN ACTH125 I-RIA KIT?

The FDA product code for SERAGAN ACTH125 I-RIA KIT is CKG.

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Other records listing Seragen Diagnostics, Inc. as applicant

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K872148VIVID CHLAMYDIA(TM)K851663QUICK-COUNT HEMATOLOGY CONTROLSK852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTE

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Related Devices (Code: CKG)

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.

K223867IDS ACTH IIImmunodiagnostic Systems LimitedK111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.

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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