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FDA 510(k)

BBL DIRECTIGEN MENINGITIS TEST KIT

K-Number: K821266 · 1982-06-01

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1982-06-01
Product CodeGRP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBL DIRECTIGEN MENINGITIS TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K821266. 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 BBL DIRECTIGEN MENINGITIS TEST KIT?

BBL DIRECTIGEN MENINGITIS TEST KIT is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821266.

When did BBL DIRECTIGEN MENINGITIS TEST KIT receive FDA 510(k) clearance?

BBL DIRECTIGEN MENINGITIS TEST KIT received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821266.

Who is the listed applicant for BBL DIRECTIGEN MENINGITIS TEST KIT?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBL DIRECTIGEN MENINGITIS TEST KIT?

The FDA product code for BBL DIRECTIGEN MENINGITIS TEST KIT is GRP.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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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.K823348H. INFLUENZA B ANTISERA FOR CIEDiagnostica, Inc.K820192HAEMOPHILUS 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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