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FDA 510(k)

ALKPHOR SYSTEM

K-Number: K823445 · 1982-12-28

ApplicantCalifornia Immuno Diagnostic, Inc.
Decision Date1982-12-28
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKPHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is California Immuno Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823445. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKPHOR SYSTEM?

ALKPHOR SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is California Immuno Diagnostic, Inc.. The 510(k) number is K823445.

When did ALKPHOR SYSTEM receive FDA 510(k) clearance?

ALKPHOR SYSTEM received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823445.

Who is the listed applicant for ALKPHOR SYSTEM?

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

What is the FDA product code for ALKPHOR SYSTEM?

The FDA product code for ALKPHOR SYSTEM is CIN.

Related Clinical Trials

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.

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Other records listing California Immuno Diagnostic, 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.

K831623DIA STRIPS SYSTEMK800698AUTOFLUOR SYSTEM

Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.

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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