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510(k) K812068

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE by Hexcel Medical — Product Code LIB

K812068 is an FDA 510(k) premarket notification submitted by Hexcel Medical for the device "PROPOSED CONTROLS FOR DOSIMETRIC RELEASE". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Hexcel Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Hexcel Medical

  • K840416 — HEXCELITE (March 23, 1984)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K812669 — SEATTLE II TOTAL HIP SYSTEM (October 2, 1981)
  • K812687 — BRIGHAM II TOTAL HIP SYSTEM (October 2, 1981)
  • K811164 — URETHANE ORTHOPAEDIC CASTING TAPE (May 27, 1981)
  • K810956 — MARCOVE HUMERAL ROD (April 17, 1981)
  • K810957 — MARCOVE INTRAMEDULLARY ROD (April 17, 1981)
  • K810230 — CONDYLAR KNEE W/METAL ENCAPSULATED TIB (March 6, 1981)
  • K800051 — HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (January 28, 1980)
  • K800050 — ANITOMIC TOTAL HIP SYSTEM (January 24, 1980)

Other clearances for product code LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)

FDA data resources