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510(k) K800605

ANA LATEX SLIDE TEST by Biologics Intl., Inc. — Product Code DHC

K800605 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "ANA LATEX SLIDE TEST". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code DHC (System, Test, Systemic Lupus Erythematosus), a Class II device regulated under 21 CFR 866.5820. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
Review Panel
IM
Submission Type

Other clearances by Biologics Intl., Inc.

  • K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (August 16, 1988)
  • K823353 — CARCINO-CEK (December 14, 1982)
  • K812060 — BI-ASO SLIDE TEST (August 13, 1981)
  • K811374 — BI-CRP LATEX TEST (June 12, 1981)
  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K791609 — BE-SURE (October 2, 1979)
  • K791607 — BETA-CELL (September 24, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

Other clearances for product code DHC

  • K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (April 9, 2001)
  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K821385 — SERO/TEX LE TEST (May 28, 1982)
  • K810981 — ANTI NDNA IMMUNOFLOURESCENT TEST SYS (April 29, 1981)
  • K810226 — SLE ANTI-N-DNA LATEX TEST (February 9, 1981)

FDA data resources