• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceGLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER
Classification Nameglucose oxidase, glucose
Generic Nameglucose oxidase, glucose
Regulation Number862.1345
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS005
Date Received08/07/2001
Decision Date08/28/2001
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling for the glucowatch(r) automatic glucose biographer.
-
-