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FDA 510(k)

POLI-MAK II

K-Number: K813102 · 1981-11-24

ApplicantPm America, Inc.
Decision Date1981-11-24
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLI-MAK II is the device name listed in this FDA 510(k) record. The listed applicant is Pm America, Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813102. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLI-MAK II?

POLI-MAK II is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Pm America, Inc.. The 510(k) number is K813102.

When did POLI-MAK II receive FDA 510(k) clearance?

POLI-MAK II received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813102.

Who is the listed applicant for POLI-MAK II?

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

What is the FDA product code for POLI-MAK II?

The FDA product code for POLI-MAK II is JJE.

Other records listing Pm America, 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.

K830319AUTO PREPK820748POLI-MAK MODEL F-4 (FINALK812983DSDK801271MODEL 4900 OFF-LINE PREPARATION SYSTEM

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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