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510(k) K821553

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT by Amf Biological And Diagnostics Co. — Product Code KHQ

K821553 is an FDA 510(k) premarket notification submitted by Amf Biological And Diagnostics Co. for the device "ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on Jun 25, 1982. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. 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
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
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)
  • K821554 — ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT (Jun 25, 1982)
  • K812329 — ZETA-SERA D (Sep 1, 1981)

Other clearances for product code KHQ

  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (Jun 10, 1998)
  • K980088 — T-UPTAKE MICROPLATE EIA (Feb 4, 1998)
  • K970539 — CHIRON DIAGNOSTICS ACS:180TU P (Mar 24, 1997)
  • K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3… (Nov 27, 1996)
  • K961488 — ELECSYS T-UPTAKE ASSAY (Jun 12, 1996)
  • K954807 — CEDIA T UPTAKE ASSAY (Dec 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (Nov 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (Jun 21, 1994)
  • K935816 — VIDAS T UPTAKE (Mar 22, 1994)

FDA data resources

Source: FDA 510(k) database entry for K821553. Report a data issue: hello@regdatalab.com.