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FDA 510(k)

SZAMYL 6.5

K-Number: K790474 · 1979-05-01

ApplicantWorthington Diagnostic Systems
Decision Date1979-05-01
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SZAMYL 6.5 is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790474. The device is classified under product code CIJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SZAMYL 6.5?

SZAMYL 6.5 is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K790474.

When did SZAMYL 6.5 receive FDA 510(k) clearance?

SZAMYL 6.5 received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790474.

Who is the listed applicant for SZAMYL 6.5?

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

What is the FDA product code for SZAMYL 6.5?

The FDA product code for SZAMYL 6.5 is CIJ.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832427EASYTOUCH TROMBOPLASTIN REAGENTK832749EASYTOUCH BUN REAGENT SETK832750EASYTOUCH HEMOGLOBIN REAGENT

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Related Devices (Code: CIJ)

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.

K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, 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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