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510(k) K915235

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT by Incstar Corp. — Product Code CDX

K915235 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT". The FDA issued a decision of Substantially Equivalent on January 28, 1992. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Incstar Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1992
Date Received
November 22, 1991
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 Incstar Corp.

  • K963289 — INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (May 1, 1997)
  • K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (December 16, 1996)
  • K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (December 16, 1996)
  • K960367 — INCSTAR RUBELLA IGG ELISA ASSAY (October 24, 1996)
  • K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY (October 24, 1996)
  • K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 (October 17, 1996)
  • K953567 — INCSTAR 25-HYDROXYVITMIN D 1251 RIA (September 25, 1996)
  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)
  • K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY (July 24, 1996)
  • K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (July 22, 1996)

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