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FDA 510(k)

UROCYSTIN

K-Number: K843382 · 1985-01-08

ApplicantMission Pharmacal Co.
Decision Date1985-01-08
Product CodeJLC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UROCYSTIN is the device name listed in this FDA 510(k) record. The listed applicant is Mission Pharmacal Co.. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K843382. The device is classified under product code JLC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROCYSTIN?

UROCYSTIN is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Mission Pharmacal Co.. The 510(k) number is K843382.

When did UROCYSTIN receive FDA 510(k) clearance?

UROCYSTIN received FDA 510(k) clearance on 1985-01-08, under 510(k) number K843382.

Who is the listed applicant for UROCYSTIN?

The FDA 510(k) record lists Mission Pharmacal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROCYSTIN?

The FDA product code for UROCYSTIN is JLC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Mission Pharmacal Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943010MAXILUBEK901223VACUUM ERECTION DEVICE (VED)

Related Devices (Code: JLC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K810514SANDARE NITROPRUSSIDE TEST PROCEDURESandare Chemical Co., Inc.

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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