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510(k) K772085

LAS-R HUMAN PLASMINOGEN TEST by Hyland Therapeutic Div., Travenol Laboratories — Product Code DDX

K772085 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LAS-R HUMAN PLASMINOGEN TEST". The FDA issued a decision of Substantially Equivalent on January 24, 1978. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1978
Date Received
November 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasminogen, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5715
Review Panel
HE
Submission Type

Other clearances by Hyland Therapeutic Div., Travenol Laboratories

  • K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM (April 26, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)
  • K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD (August 18, 1981)
  • K810078 — Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (February 2, 1981)
  • K810077 — OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (January 28, 1981)
  • K802610 — ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (January 5, 1981)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)

Other clearances for product code DDX

  • K941346 — PLASMINOGEN RID TEST KIT (September 9, 1994)
  • K884766 — BERICHROM(R) PLASMINOGEN (January 4, 1989)
  • K864212 — IL TEST 97573-15, PLASMINOGEN ASSAY (December 4, 1986)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K832591 — DIACROM *PLG (November 21, 1983)
  • K812625 — ACA PLASMINOGEN TEST PACK (September 29, 1981)
  • K811777 — HELENA PLASMINOGEN QUIPLATE PROCEDURE (July 2, 1981)
  • K781478 — PLASMINOGEN ASSAY (November 15, 1978)

FDA data resources