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FDA 510(k)

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

K-Number: K970277 · 1997-12-11

ApplicantAstoria-Pacific, Inc.
Decision Date1997-12-11
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) is the device name listed in this FDA 510(k) record. The listed applicant is Astoria-Pacific, Inc.. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K970277. The device is classified under product code KQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)?

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Astoria-Pacific, Inc.. The 510(k) number is K970277.

When did URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) receive FDA 510(k) clearance?

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) received FDA 510(k) clearance on 1997-12-11, under 510(k) number K970277.

Who is the listed applicant for URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)?

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

What is the FDA product code for URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)?

The FDA product code for URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) is KQP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Astoria-Pacific, 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.

K121101SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITK102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITK101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DK090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDK080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITK010844ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

View all 9 devices →

Related Devices (Code: KQP)

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.

K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITAstoria-Pacific, Inc.K101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DAstoria-Pacific, Inc.K100101GSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.K993536BIO-RAD CODA NEONATAL GALT ASSAYBio-RadK990827MICROPLATE NEONATAL GALT ASSAYBio-RadK894011TOTAL GALACTOSEAlpkem Corp.

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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