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FDA 510(k)

H-FLU B ELISA TEST

K-Number: K831525 · 1983-09-29

ApplicantSeragen Diagnostics, Inc.
Decision Date1983-09-29
Product CodeGRP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H-FLU B ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K831525. 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-FLU B ELISA TEST?

H-FLU B ELISA TEST is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K831525.

When did H-FLU B ELISA TEST receive FDA 510(k) clearance?

H-FLU B ELISA TEST received FDA 510(k) clearance on 1983-09-29, under 510(k) number K831525.

Who is the listed applicant for H-FLU B ELISA TEST?

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

What is the FDA product code for H-FLU B ELISA TEST?

The FDA product code for H-FLU B ELISA TEST is GRP.

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Other records listing Seragen Diagnostics, 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.

K872148VIVID CHLAMYDIA(TM)K851663QUICK-COUNT HEMATOLOGY CONTROLSK852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTE

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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 ScanK823348H. INFLUENZA B ANTISERA FOR CIEDiagnostica, 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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