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FDA 510(k)

RIM-HAEMOPHILUS 1 & 2

K-Number: K832051 · 1983-08-12

ApplicantAustin Biological Laboratories
Decision Date1983-08-12
Product CodeJST
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RIM-HAEMOPHILUS 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832051. The device is classified under product code JST. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIM-HAEMOPHILUS 1 & 2?

RIM-HAEMOPHILUS 1 & 2 is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Austin Biological Laboratories. The 510(k) number is K832051.

When did RIM-HAEMOPHILUS 1 & 2 receive FDA 510(k) clearance?

RIM-HAEMOPHILUS 1 & 2 received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832051.

Who is the listed applicant for RIM-HAEMOPHILUS 1 & 2?

The FDA 510(k) record lists Austin Biological Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIM-HAEMOPHILUS 1 & 2?

The FDA product code for RIM-HAEMOPHILUS 1 & 2 is JST.

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Other records listing Austin Biological Laboratories 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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862560PRECEPT CEFTIZOXIMEK862446PRECEPT CEFTAZIDIME

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Related Devices (Code: JST)

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.

K962423BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEMBecton Dickinson Microbiology SystemsK854732API 50 CHB (CULTURE MEDIA)Dms Products, Inc.K841661SYNTHETIC BROTH A.O.A.C.Oxoid U.S.A., Inc.K832239RIM-HAEMOPHILUS 2Austin Biological LaboratoriesK831349STREPTOCOCUS ID PLATEGranite Diagnostics, 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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