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FDA 510(k)

GRAM STAIN

K-Number: K843050 · 1984-09-11

ApplicantReagent Laboratory, Inc.
Decision Date1984-09-11
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GRAM STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K843050. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM STAIN?

GRAM STAIN is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K843050.

When did GRAM STAIN receive FDA 510(k) clearance?

GRAM STAIN received FDA 510(k) clearance on 1984-09-11, under 510(k) number K843050.

Who is the listed applicant for GRAM STAIN?

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

What is the FDA product code for GRAM STAIN?

The FDA product code for GRAM STAIN is JTS.

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Other records listing Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK842785STAIN, METHYLENE BLUE-EOSIN

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Related Devices (Code: JTS)

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.

K960090CALCOFLUOR WHITE STAIN KITRemel Co.K960095BACTIDROP CALCOFLUOR WHITERemel Co.K920970BACTIDROP KOH (10%)Remel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K920976BACTIDROP INDIA INKRemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems

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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