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 Solution, Decalcifier, Acid Containing
510(k) Number K850636
Device Name SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
Applicant
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Applicant Contact JACK C MCLAUGHLIN
Correspondent
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Correspondent Contact JACK C MCLAUGHLIN
Regulation Number864.4010
Classification Product Code
KDX  
Date Received02/19/1985
Decision Date 03/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-