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510(k) K884496

RIA/MAT FPA TEST KIT by Altana, Inc. — Product Code DAN

K884496 is an FDA 510(k) premarket notification submitted by Altana, Inc. for the device "RIA/MAT FPA TEST KIT". The FDA issued a decision of Substantially Equivalent on November 16, 1988. The device falls under product code DAN (Fibrinopeptide A, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5350. Altana, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
October 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinopeptide A, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5350
Review Panel
IM
Submission Type

Other clearances by Altana, Inc.

  • K934205 — SEARCH-SONIC (June 21, 1994)

Other clearances for product code DAN

  • K854384 — ASSERACHROM FPA KIT (February 4, 1986)
  • K821151 — RIA-QUANT FPA TEST KIT (July 22, 1982)

FDA data resources