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 Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
510(k) Number K780652
Device Name HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2
Applicant
The London Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The London Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3220
Classification Product Code
JKS  
Date Received04/17/1978
Decision Date 07/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-