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FDA 510(k)

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL

K-Number: K111363 · 2011-12-06

ApplicantMedica Corp.
Decision Date2011-12-06
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2011-12-06 under 510(k) number K111363. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL?

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL is a medical device that received FDA 510(k) clearance on 2011-12-06. The listed applicant is Medica Corp.. The 510(k) number is K111363.

When did PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL receive FDA 510(k) clearance?

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL received FDA 510(k) clearance on 2011-12-06, under 510(k) number K111363.

Who is the listed applicant for PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL?

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

What is the FDA product code for PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL?

The FDA product code for PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL is JXN.

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Other records listing Medica Corp. as applicant

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K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORK101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

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Related Devices (Code: JXN)

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.

K122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDBranan Medical Corp.K043303ONLINE DAT PROPOXYPHENE PLUSRoche Diagnostics Corp.K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEACON Laboratories, Inc.K030835'RAPID ONE' - PROPOXYPHENE TESTAmerican Bio Medica Corp.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.K022915INSTANT-VIEW PROPOXYPHENE (PPX) URINE TESTAlfa Scientific Designs, 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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