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FDA 510(k)

COUNT-10 TROL

K-Number: K822540 · 1982-10-08

ApplicantTexas Immunology, Inc.
Decision Date1982-10-08
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COUNT-10 TROL is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1982-10-08 under 510(k) number K822540. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUNT-10 TROL?

COUNT-10 TROL is a medical device that received FDA 510(k) clearance on 1982-10-08. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K822540.

When did COUNT-10 TROL receive FDA 510(k) clearance?

COUNT-10 TROL received FDA 510(k) clearance on 1982-10-08, under 510(k) number K822540.

Who is the listed applicant for COUNT-10 TROL?

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

What is the FDA product code for COUNT-10 TROL?

The FDA product code for COUNT-10 TROL is JJW.

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Other records listing Texas Immunology, Inc. as applicant

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Related Devices (Code: JJW)

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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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