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FDA 510(k)

HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK

K-Number: K833665 · 1983-11-25

ApplicantJ.S. Medical Assoc.
Decision Date1983-11-25
Product CodeHYF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1983-11-25 under 510(k) number K833665. 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 HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK?

HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK is a medical device that received FDA 510(k) clearance on 1983-11-25. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K833665.

When did HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK receive FDA 510(k) clearance?

HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK received FDA 510(k) clearance on 1983-11-25, under 510(k) number K833665.

Who is the listed applicant for HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK?

The FDA 510(k) record lists J.S. Medical Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK?

The FDA product code for HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK is HYF.

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Other records listing J.S. Medical Assoc. as applicant

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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.K833677QUICK STAIN WRIGHT'S GIEMSA W/BUFFJ.S. Medical Assoc.K831131CASE WRIGHT-GIEMSA STAIN PAKCase Instruments

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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