UNI-PLATE

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

MEDICAL SPECIALTIES LABORATORIES

The following data is part of a premarket notification filed by Medical Specialties Laboratories with the FDA for Uni-plate.

Pre-market Notification Details

• Device ID: K852643
• 510k Number: K852643
• Device Name: UNI-PLATE
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: MEDICAL SPECIALTIES LABORATORIES P.O.BOX 659, KENMORE STATION Boston, MA 02215
• Contact: Judith A Beatrice
• Correspondent: Judith A Beatrice; MEDICAL SPECIALTIES LABORATORIES P.O.BOX 659, KENMORE STATION Boston, MA 02215
• Product Code: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-06-21
• Decision Date: 1985-08-08