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FDA 510(k)

SICKLE CELL TEST KIT

K-Number: K932872 · 1993-08-16

ApplicantHisto-Med, Inc.
Decision Date1993-08-16
Product CodeJBB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE CELL TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Histo-Med, Inc.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K932872. The device is classified under product code JBB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICKLE CELL TEST KIT?

SICKLE CELL TEST KIT is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Histo-Med, Inc.. The 510(k) number is K932872.

When did SICKLE CELL TEST KIT receive FDA 510(k) clearance?

SICKLE CELL TEST KIT received FDA 510(k) clearance on 1993-08-16, under 510(k) number K932872.

Who is the listed applicant for SICKLE CELL TEST KIT?

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

What is the FDA product code for SICKLE CELL TEST KIT?

The FDA product code for SICKLE CELL TEST KIT is JBB.

Related Clinical Trials

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.

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Related Devices (Code: JBB)

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.

K895745SICKLE CELL SOLUBILITY TEST KITSimmler, 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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