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FDA 510(k)

ACTH NORMAL RANGE

K-Number: K842249 · 1984-08-15

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1984-08-15
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTH NORMAL RANGE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842249. 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 ACTH NORMAL RANGE?

ACTH NORMAL RANGE is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K842249.

When did ACTH NORMAL RANGE receive FDA 510(k) clearance?

ACTH NORMAL RANGE received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842249.

Who is the listed applicant for ACTH NORMAL RANGE?

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

What is the FDA product code for ACTH NORMAL RANGE?

The FDA product code for ACTH NORMAL RANGE is CKG.

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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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