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FDA 510(k)

HEMACOUNT WRIGHT GIEMSA STAIN PACK

K-Number: K822602 · 1982-09-17

ApplicantAccra Laboratories, Inc.
Decision Date1982-09-17
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEMACOUNT WRIGHT GIEMSA STAIN PACK 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 1982-09-17 under 510(k) number K822602. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMACOUNT WRIGHT GIEMSA STAIN PACK?

HEMACOUNT WRIGHT GIEMSA STAIN PACK is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K822602.

When did HEMACOUNT WRIGHT GIEMSA STAIN PACK receive FDA 510(k) clearance?

HEMACOUNT WRIGHT GIEMSA STAIN PACK received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822602.

Who is the listed applicant for HEMACOUNT WRIGHT GIEMSA STAIN PACK?

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 HEMACOUNT WRIGHT GIEMSA STAIN PACK?

The FDA product code for HEMACOUNT WRIGHT GIEMSA STAIN PACK is JAF.

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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.

K851493KINYOUN ACID FAST STAIN KITK851494TWO-STEP ACID FAST BACTERIA STAINK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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