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510(k) K881064

HYGEIA GC TEST by Hygeia Sciences — Product Code LIR

K881064 is an FDA 510(k) premarket notification submitted by Hygeia Sciences for the device "HYGEIA GC TEST". The FDA issued a decision of Substantially Equivalent on June 2, 1988. The device falls under product code LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Hygeia Sciences has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1988
Date Received
March 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances by Hygeia Sciences

  • K882192 — HYGEIA URINE PREGNANCY TEST (November 10, 1988)
  • K862083 — HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (July 2, 1986)
  • K862133 — HYGEIA RAPID STREP A TEST (June 25, 1986)

Other clearances for product code LIR

  • K023947 — GC OIA (April 17, 2003)
  • K882534 — ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (July 12, 1988)

FDA data resources