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FDA 510(k)

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

K-Number: K090940 · 2009-12-14

ApplicantAstoria-Pacific, Inc.
Decision Date2009-12-14
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED 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 2009-12-14 under 510(k) number K090940. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTCHECK BLOOD SPOT CONTROL, ASSAYED?

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED is a medical device that received FDA 510(k) clearance on 2009-12-14. The listed applicant is Astoria-Pacific, Inc.. The 510(k) number is K090940.

When did SPOTCHECK BLOOD SPOT CONTROL, ASSAYED receive FDA 510(k) clearance?

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED received FDA 510(k) clearance on 2009-12-14, under 510(k) number K090940.

Who is the listed applicant for SPOTCHECK BLOOD SPOT CONTROL, ASSAYED?

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 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED?

The FDA product code for SPOTCHECK BLOOD SPOT CONTROL, ASSAYED is JJT.

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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 350DK080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITK010844ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13KK990957ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

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Related Devices (Code: JJT)

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.

K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-RadK993723CARDIASURE CARDIAC MARKERS CONTROLQuantimetrix 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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