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FDA 510(k)

RESPIRACULT-STREP DEEP BED CULTURE PAD

K-Number: K821659 · 1982-08-05

ApplicantOrion Diagnostica, Inc.
Decision Date1982-08-05
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESPIRACULT-STREP DEEP BED CULTURE PAD is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1982-08-05 under 510(k) number K821659. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRACULT-STREP DEEP BED CULTURE PAD?

RESPIRACULT-STREP DEEP BED CULTURE PAD is a medical device that received FDA 510(k) clearance on 1982-08-05. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K821659.

When did RESPIRACULT-STREP DEEP BED CULTURE PAD receive FDA 510(k) clearance?

RESPIRACULT-STREP DEEP BED CULTURE PAD received FDA 510(k) clearance on 1982-08-05, under 510(k) number K821659.

Who is the listed applicant for RESPIRACULT-STREP DEEP BED CULTURE PAD?

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

What is the FDA product code for RESPIRACULT-STREP DEEP BED CULTURE PAD?

The FDA product code for RESPIRACULT-STREP DEEP BED CULTURE PAD is JSH.

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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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