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FDA 510(k)

MEZLIN DIAGNOSTIC REAGENT

K-Number: K820578 · 1982-05-12

ApplicantMiles Pharmaceuticals
Decision Date1982-05-12
Product CodeJTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEZLIN DIAGNOSTIC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Miles Pharmaceuticals. It received FDA 510(k) clearance on 1982-05-12 under 510(k) number K820578. The device is classified under product code JTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEZLIN DIAGNOSTIC REAGENT?

MEZLIN DIAGNOSTIC REAGENT is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is Miles Pharmaceuticals. The 510(k) number is K820578.

When did MEZLIN DIAGNOSTIC REAGENT receive FDA 510(k) clearance?

MEZLIN DIAGNOSTIC REAGENT received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820578.

Who is the listed applicant for MEZLIN DIAGNOSTIC REAGENT?

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

What is the FDA product code for MEZLIN DIAGNOSTIC REAGENT?

The FDA product code for MEZLIN DIAGNOSTIC REAGENT is JTT.

Related Clinical Trials

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Other records listing Miles Pharmaceuticals 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.

K872081CIPRO (TM) DIAGNOSTIC POWDER

Related Devices (Code: JTT)

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.

K983310SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACINAccumed Intl., Inc.K935805PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.K895362BACTEC PYRAZINAMIDE SUSCEPTIBILITY TESTBd Becton Dickinson Vacutainer Systems PreanalyticK880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK872081CIPRO (TM) DIAGNOSTIC POWDERMiles PharmaceuticalsK864442NORFLOXACIN SUSCEPTIBILITY POWDERMerck, Sharp & Dohme

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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