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FDA 510(k)

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909

K-Number: K854716 · 1986-01-07

ApplicantNobel Scientific Industries, Inc.
Decision Date1986-01-07
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1986-01-07 under 510(k) number K854716. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909?

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K854716.

When did NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 receive FDA 510(k) clearance?

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 received FDA 510(k) clearance on 1986-01-07, under 510(k) number K854716.

Who is the listed applicant for NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909?

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

What is the FDA product code for NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909?

The FDA product code for NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 is CIC.

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Other records listing Nobel Scientific Industries, 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.

K854717NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928K854718NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926K850944NSI LYSING-D REAGENT -4000 MLK844782NSI ELT-D DILUTING FLUID 4000MLK823283FLUSHING SOLUTIONK812866ASTRA REAGENT CONCENTRATE SYSTEM

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Related Devices (Code: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, 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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