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FDA 510(k)

BACI 6 -ADRENOCORTICOTROOP HORMONE

K-Number: K850053 · 1985-04-08

ApplicantEuro-Diagnostics BV
Decision Date1985-04-08
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BACI 6 -ADRENOCORTICOTROOP HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostics BV. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850053. 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 BACI 6 -ADRENOCORTICOTROOP HORMONE?

BACI 6 -ADRENOCORTICOTROOP HORMONE is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Euro-Diagnostics BV. The 510(k) number is K850053.

When did BACI 6 -ADRENOCORTICOTROOP HORMONE receive FDA 510(k) clearance?

BACI 6 -ADRENOCORTICOTROOP HORMONE received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850053.

Who is the listed applicant for BACI 6 -ADRENOCORTICOTROOP HORMONE?

The FDA 510(k) record lists Euro-Diagnostics BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BACI 6 -ADRENOCORTICOTROOP HORMONE?

The FDA product code for BACI 6 -ADRENOCORTICOTROOP HORMONE is CKG.

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Other records listing Euro-Diagnostics BV 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.

K851332BLHI LUTEINIZING HORMONEK851148TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONEK843930IRMA IMMUNORADIOMETRIC ASSAY-FSH 125IK842478PROLACTIN IRMA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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