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FDA 510(k)

REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

K-Number: K864862 · 1987-02-20

ApplicantHf Scientific, Inc.
Decision Date1987-02-20
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. is the device name listed in this FDA 510(k) record. The listed applicant is Hf Scientific, Inc.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K864862. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.?

REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is Hf Scientific, Inc.. The 510(k) number is K864862.

When did REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. receive FDA 510(k) clearance?

REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. received FDA 510(k) clearance on 1987-02-20, under 510(k) number K864862.

Who is the listed applicant for REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.?

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

What is the FDA product code for REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.?

The FDA product code for REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. is JGS.

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Other records listing Hf Scientific, 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.

K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.K880967MICRO CO2 APPARATUSK874429HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12K864313CO2 REAGENT SET

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

Official Source

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