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FDA 510(k)

X-ACT UREA/TDA

K-Number: K883995 · 1988-10-12

ApplicantPro-Lab, Inc.
Decision Date1988-10-12
Product CodeJSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

X-ACT UREA/TDA is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883995. The device is classified under product code JSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-ACT UREA/TDA?

X-ACT UREA/TDA is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K883995.

When did X-ACT UREA/TDA receive FDA 510(k) clearance?

X-ACT UREA/TDA received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883995.

Who is the listed applicant for X-ACT UREA/TDA?

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

What is the FDA product code for X-ACT UREA/TDA?

The FDA product code for X-ACT UREA/TDA is JSE.

Other records listing Pro-Lab, Inc. 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.

K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)K914419AMNIOTEST(TM)K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK903714E. COLI 0157 LATEX TESTK894221ROSCO PYRRK883996X-ACT LDC/IND

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Related Devices (Code: JSE)

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.

K962265MLX MICROTITER PLATE LUMINOMETERDynatech Laboratories, Inc.K883996X-ACT LDC/INDPro-Lab, Inc.K880116MRVP BROTHHardy MediaK880133MIL MEDIUMHardy MediaK874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARLakewood Biochemical Co., Inc.K871096CYSTINE TRYPTIC AGAR W/O CARBOHYDRATESbioMerieux, 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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