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FDA 510(k)

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

K-Number: K010844 · 2001-09-21

ApplicantAstoria-Pacific, Inc.
Decision Date2001-09-21
Product CodeNAK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K 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 2001-09-21 under 510(k) number K010844. The device is classified under product code NAK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K?

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Astoria-Pacific, Inc.. The 510(k) number is K010844.

When did ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K receive FDA 510(k) clearance?

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K received FDA 510(k) clearance on 2001-09-21, under 510(k) number K010844.

Who is the listed applicant for ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K?

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 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K?

The FDA product code for ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K is NAK.

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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 KITK990957ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

View all 9 devices →

Related Devices (Code: NAK)

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.

K131284GSP NEONATAL BIOTINIDASE KITWallac OYK090123NEONATAL BIOTINIDASE KIT, MODEL 3018Perkinelmer, Inc.K080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITAstoria-Pacific, 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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