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510(k) K821554

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT by Amf Biological And Diagnostics Co. — Product Code CDX

K821554 is an FDA 510(k) premarket notification submitted by Amf Biological And Diagnostics Co. for the device "ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT". The FDA issued a decision of Substantially Equivalent on Jun 25, 1982. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Amf Biological And Diagnostics Co. has 4 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 25, 1982
Date Received
May 25, 1982
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
510(k) Exempt

Other clearances by Amf Biological And Diagnostics Co.

  • K852418 — QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) (Jul 15, 1985)
  • K821931 — ZETA-CORT (Jul 22, 1982)
  • K821553 — ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT (Jun 25, 1982)
  • K812329 — ZETA-SERA D (Sep 1, 1981)

Other clearances for product code CDX

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

FDA data resources

Source: FDA 510(k) database entry for K821554. Report a data issue: hello@regdatalab.com.