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FDA 510(k)

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT

K-Number: K831100 · 1983-05-04

ApplicantMedical Diagnostics, Ca.
Decision Date1983-05-04
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostics, Ca.. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K831100. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICA IIF-MULTIPLE ANTIBODY TEST KIT?

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Medical Diagnostics, Ca.. The 510(k) number is K831100.

When did MEDICA IIF-MULTIPLE ANTIBODY TEST KIT receive FDA 510(k) clearance?

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT received FDA 510(k) clearance on 1983-05-04, under 510(k) number K831100.

Who is the listed applicant for MEDICA IIF-MULTIPLE ANTIBODY TEST KIT?

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

What is the FDA product code for MEDICA IIF-MULTIPLE ANTIBODY TEST KIT?

The FDA product code for MEDICA IIF-MULTIPLE ANTIBODY TEST KIT is DBM.

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Other records listing Medical Diagnostics, Ca. 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.

K853140MDI QUIK TEST NARCOTICS DRUG SCREENK843900FOCUSCOPE UNIVERSAL SYSTEMK843343MEDICA IIF-ANTI-THYROID ANTIBODY TEST

Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, Inc.

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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