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FDA 510(k)

H. INFLUENZA B ANTISERA FOR CIE

K-Number: K823348 · 1982-12-28

ApplicantDiagnostica, Inc.
Decision Date1982-12-28
Product CodeGRP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H. INFLUENZA B ANTISERA FOR CIE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823348. The device is classified under product code GRP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H. INFLUENZA B ANTISERA FOR CIE?

H. INFLUENZA B ANTISERA FOR CIE is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Diagnostica, Inc.. The 510(k) number is K823348.

When did H. INFLUENZA B ANTISERA FOR CIE receive FDA 510(k) clearance?

H. INFLUENZA B ANTISERA FOR CIE received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823348.

Who is the listed applicant for H. INFLUENZA B ANTISERA FOR CIE?

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

What is the FDA product code for H. INFLUENZA B ANTISERA FOR CIE?

The FDA product code for H. INFLUENZA B ANTISERA FOR CIE is GRP.

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Other records listing Diagnostica, 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.

K002756EASE-A-CULTK812434DIAGNOSTIC KITS & KIT COMPONENTSK800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTK791281ANTI-HUMAN IGG SERUMK791283ANTI-HUMAN LAMBDA SERUMK791284ANTI-HUMAN KAPPA SERUM

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Related Devices (Code: GRP)

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.

K884967BACTIGEN(R) H. INFLUENZAE TYPE BArmkel, LLCK854490IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TESAmerican Micro ScanK831525H-FLU B ELISA TESTSeragen Diagnostics, Inc.K821266BBL DIRECTIGEN MENINGITIS TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK820192HAEMOPHILUS INFLUENZAE TYPE B ANTISERUMHyland Therapeutic Div., Travenol Laboratories

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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