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510(k) K862669

ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST by U. S. Diagnostics, Inc. — Product Code GFD

K862669 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST". The FDA issued a decision of Substantially Equivalent on October 3, 1986. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1986
Date Received
July 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dermatome
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by U. S. Diagnostics, Inc.

  • K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (September 21, 2011)
  • K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (February 20, 2009)
  • K061431 — EASYGLUCO, MODEL IGM-0002 G2 (January 12, 2007)
  • K051651 — G4, MODEL IGM-0004 (April 14, 2006)
  • K870685 — COAGULATION CONTROL, LEVEL I (April 20, 1987)
  • K870596 — PROTHROMBIN TIME TEST (April 20, 1987)
  • K870687 — COAGULATION CONTROL, LEVEL III (April 20, 1987)
  • K870686 — COAGULATION CONTROL, LEVEL II (April 20, 1987)
  • K871283 — CYANMETHEMOGLOBIN STANDARD (April 15, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)

Other clearances for product code GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 1996)
  • K962371 — DERMTOME BLADE (August 29, 1996)
  • K945594 — DECA DERMATOME (MICROMOTOR SYSTEM) (June 5, 1995)
  • K951085 — PADGETT AIR DERMATOME, MODEL A (May 15, 1995)
  • K940208 — AESCULAP ACCU-DERMATOME (February 24, 1994)
  • K861285 — SKIN MESH DEVICE (April 17, 1986)
  • K861138 — MASH DERMATOME (April 14, 1986)
  • K860925 — DERMASPANDERE (March 28, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)
  • K830993 — AMPLIGREFFE (May 3, 1983)

FDA data resources