Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
510(k) Number K875248
Device Name BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
Applicant
Bioscan Instruments, Inc.
39w 32nd St.
New York,  NY  10001
Applicant Contact PAUL U JU
Correspondent
Bioscan Instruments, Inc.
39w 32nd St.
New York,  NY  10001
Correspondent Contact PAUL U JU
Regulation Number862.1510
Classification Product Code
JMT  
Date Received12/22/1987
Decision Date 02/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-