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FDA 510(k)

BLOODBORNE PATHOGEN KIT

K-Number: K953102 · 1995-12-11

ApplicantCertified Safety Mfg., Inc.
Decision Date1995-12-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLOODBORNE PATHOGEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Certified Safety Mfg., Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K953102. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOODBORNE PATHOGEN KIT?

BLOODBORNE PATHOGEN KIT is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K953102.

When did BLOODBORNE PATHOGEN KIT receive FDA 510(k) clearance?

BLOODBORNE PATHOGEN KIT received FDA 510(k) clearance on 1995-12-11, under 510(k) number K953102.

Who is the listed applicant for BLOODBORNE PATHOGEN KIT?

The FDA 510(k) record lists Certified Safety Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOODBORNE PATHOGEN KIT?

The FDA product code for BLOODBORNE PATHOGEN KIT is FXX.

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Other records listing Certified Safety Mfg., Inc. as applicant

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Related Devices (Code: FXX)

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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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