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FDA 510(k)

GRAM STAIN SET W/STABILIZED IODINE

K-Number: K843429 · 1984-09-14

ApplicantAccra Laboratories, Inc.
Decision Date1984-09-14
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GRAM STAIN SET W/STABILIZED IODINE is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K843429. 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 SET W/STABILIZED IODINE?

GRAM STAIN SET W/STABILIZED IODINE is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K843429.

When did GRAM STAIN SET W/STABILIZED IODINE receive FDA 510(k) clearance?

GRAM STAIN SET W/STABILIZED IODINE received FDA 510(k) clearance on 1984-09-14, under 510(k) number K843429.

Who is the listed applicant for GRAM STAIN SET W/STABILIZED IODINE?

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

What is the FDA product code for GRAM STAIN SET W/STABILIZED IODINE?

The FDA product code for GRAM STAIN SET W/STABILIZED IODINE is JTS.

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Other records listing Accra Laboratories, 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.

K851494TWO-STEP ACID FAST BACTERIA STAINK851493KINYOUN ACID FAST STAIN KITK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

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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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