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FDA 510(k)

HATCH KIT

K-Number: K831855 · 1983-07-28

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1983-07-28
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HATCH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831855. 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 HATCH KIT?

HATCH KIT is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K831855.

When did HATCH KIT receive FDA 510(k) clearance?

HATCH KIT received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831855.

Who is the listed applicant for HATCH KIT?

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

What is the FDA product code for HATCH KIT?

The FDA product code for HATCH KIT is CKG.

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Other records listing Radioassay Systems Laboratories, Inc. 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.

K862204RSL (125I) ALDOSTERONE KITK842960ANDROSTENEDIONE BY RIAK840886HYDROXYPROGESTERONE BY RIA 17AK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KITK791999(125I) TESTOSTERONE KIT

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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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