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FDA 510(k)

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR

K-Number: K991618 · 2001-01-24

ApplicantPropper Mfg. Co., Inc.
Decision Date2001-01-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Propper Mfg. Co., Inc.. It received FDA 510(k) clearance on 2001-01-24 under 510(k) number K991618. 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 BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR?

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR is a medical device that received FDA 510(k) clearance on 2001-01-24. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K991618.

When did BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR receive FDA 510(k) clearance?

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR received FDA 510(k) clearance on 2001-01-24, under 510(k) number K991618.

Who is the listed applicant for BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR?

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

What is the FDA product code for BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR?

The FDA product code for BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR is FRC.

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Other records listing Propper Mfg. Co., Inc. as applicant

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Related Devices (Code: FRC)

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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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