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510(k) K962176

TPP by Panbio, Inc. — Product Code MIF

K962176 is an FDA 510(k) premarket notification submitted by Panbio, Inc. for the device "TPP". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code MIF (Prothrombin Fragment 1.2), a Class II device regulated under 21 CFR 864.7320. Panbio, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
June 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin Fragment 1.2
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by Panbio, Inc.

  • K002024 — PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODI (November 22, 2000)
  • K970189 — FIF TM (May 21, 1997)
  • K910636 — ABS CADKIT (April 29, 1991)

Other clearances for product code MIF

  • K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT (December 10, 2004)
  • K964934 — THROMBONOSTIKA F1.2 (March 18, 1997)
  • K922934 — ENZYGNOST F 1+2 (November 16, 1992)
  • K920895 — DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (June 4, 1992)
  • K911434 — THROMBONOSTIKA F1.2 (October 31, 1991)

FDA data resources