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510(k) K791282

ANTI-HUMAN SERUM by Diagnostica, Inc. — Product Code DGQ

K791282 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "ANTI-HUMAN SERUM". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code DGQ (Whole Blood Plasma, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5700. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
July 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Blood Plasma, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5700
Review Panel
HE
Submission Type

Other clearances by Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

FDA data resources