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FDA 510(k)

CASE WRIGHT-GIEMSA STAIN PAK

K-Number: K831131 · 1983-06-08

ApplicantCase Instruments
Decision Date1983-06-08
Product CodeHYF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CASE WRIGHT-GIEMSA STAIN PAK is the device name listed in this FDA 510(k) record. The listed applicant is Case Instruments. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831131. The device is classified under product code HYF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASE WRIGHT-GIEMSA STAIN PAK?

CASE WRIGHT-GIEMSA STAIN PAK is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Case Instruments. The 510(k) number is K831131.

When did CASE WRIGHT-GIEMSA STAIN PAK receive FDA 510(k) clearance?

CASE WRIGHT-GIEMSA STAIN PAK received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831131.

Who is the listed applicant for CASE WRIGHT-GIEMSA STAIN PAK?

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

What is the FDA product code for CASE WRIGHT-GIEMSA STAIN PAK?

The FDA product code for CASE WRIGHT-GIEMSA STAIN PAK is HYF.

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Related Devices (Code: HYF)

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.

K842742GIEMSA STAINE K Ind., Inc.K833665HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACKJ.S. Medical Assoc.K833677QUICK STAIN WRIGHT'S GIEMSA W/BUFFJ.S. Medical Assoc.

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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