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FDA 510(k)

STAT STAIN SET

K-Number: K810495 · 1981-03-17

ApplicantAccra Laboratories, Inc.
Decision Date1981-03-17
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAT STAIN SET 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 1981-03-17 under 510(k) number K810495. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT STAIN SET?

STAT STAIN SET is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K810495.

When did STAT STAIN SET receive FDA 510(k) clearance?

STAT STAIN SET received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810495.

Who is the listed applicant for STAT STAIN SET?

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 STAT STAIN SET?

The FDA product code for STAT STAIN SET is IAF.

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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: IAF)

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.

K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma Diagnostics, Inc.K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLCK852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon 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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