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FDA 510(k)

ACON URINALYSIS REAGENT STRIPS

K-Number: K061559 · 2006-08-11

ApplicantAcon Laboratories Co.
Decision Date2006-08-11
Product CodeCDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACON URINALYSIS REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Acon Laboratories Co.. It received FDA 510(k) clearance on 2006-08-11 under 510(k) number K061559. The device is classified under product code CDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON URINALYSIS REAGENT STRIPS?

ACON URINALYSIS REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2006-08-11. The listed applicant is Acon Laboratories Co.. The 510(k) number is K061559.

When did ACON URINALYSIS REAGENT STRIPS receive FDA 510(k) clearance?

ACON URINALYSIS REAGENT STRIPS received FDA 510(k) clearance on 2006-08-11, under 510(k) number K061559.

Who is the listed applicant for ACON URINALYSIS REAGENT STRIPS?

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

What is the FDA product code for ACON URINALYSIS REAGENT STRIPS?

The FDA product code for ACON URINALYSIS REAGENT STRIPS is CDM.

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Other records listing Acon Laboratories 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.

K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEMK023766ACON STREP A TWIST TEST DEVICEK020313ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICEK010582ACON STREP A RAPID TEST STRIPK980736ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

Related Devices (Code: CDM)

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.

K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State UniversityK873366WAKO(TM) PRETEST 5AWako Chemicals USA, Inc.K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.K821799FITKIT I CHECKUP KITPatton, Boggs & BlowK830340FITKIT I CHECKUP KITBoditestor

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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