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FDA 510(k)

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR

K-Number: K994381 · 2001-03-30

ApplicantRaven Biological Laboratories, Inc.
Decision Date2001-03-30
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Raven Biological Laboratories, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K994381. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR?

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Raven Biological Laboratories, Inc.. The 510(k) number is K994381.

When did PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR receive FDA 510(k) clearance?

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR received FDA 510(k) clearance on 2001-03-30, under 510(k) number K994381.

Who is the listed applicant for PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR?

The FDA 510(k) record lists Raven Biological Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR?

The FDA product code for PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR is FRC.

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Other records listing Raven Biological Laboratories, Inc. as applicant

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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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