FDA 510(k)

UREA-PDA DISK

K-Number: K830396 · 1983-03-08

Decision Date1983-03-08

Product CodeJSS

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

UREA-PDA DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1983-03-08 under 510(k) number K830396. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA-PDA DISK?

UREA-PDA DISK is a medical device that received FDA 510(k) clearance on 1983-03-08. The listed applicant is Remel Co.. The 510(k) number is K830396.

When did UREA-PDA DISK receive FDA 510(k) clearance?

UREA-PDA DISK received FDA 510(k) clearance on 1983-03-08, under 510(k) number K830396.

Who is the listed applicant for UREA-PDA DISK?

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

What is the FDA product code for UREA-PDA DISK?

The FDA product code for UREA-PDA DISK is JSS.

Other records listing Remel 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.

K013711BACTI-SWAB DRY K965151A.C.T. III K965150A.C.T. IV K965152A.C.T. II K965149A.C.T. I K960090CALCOFLUOR WHITE STAIN KIT

View all 137 devices →

Related Devices (Code: JSS)

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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.