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510(k) K771606

IMMUNOSPOT NEONATAL T4 TEST by Meloy Laboratories, Inc. — Product Code CDX

K771606 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "IMMUNOSPOT NEONATAL T4 TEST". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Meloy Laboratories, Inc.

  • K852033 — SS-A(RO) & SS-B(LA) ANTIBODY ASSAY (June 21, 1985)
  • K844678 — MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL (January 4, 1985)
  • K841708 — MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII (July 19, 1984)
  • K842247 — MELOY AUTOANTIBODY TEST SYS (June 26, 1984)
  • K831292 — ANTI-ENA TEST (July 18, 1983)
  • K820265 — ANA TEST (MOUSE LIVER SUBSTRATE) (February 12, 1982)
  • K820005 — TOTAL HEMOLYTIC COMPLEMENT TEST KIT (January 22, 1982)
  • K811178 — HUMAN IGG-ALBUMIN TEST KIT (May 15, 1981)
  • K792562 — IMMUNOSTAT TSH TEST (January 16, 1980)
  • K791493 — ANTI-NUCLEAR ANTIBODY TEST (September 24, 1979)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources