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510(k) K811725

TBG DIAGNOSTIC KIT by Immuno Assay Corp. — Product Code CEF

K811725 is an FDA 510(k) premarket notification submitted by Immuno Assay Corp. for the device "TBG DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Immuno Assay Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

Other clearances by Immuno Assay Corp.

  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K833745 — RIACOAT T-4 (January 4, 1984)
  • K820089 — TSH (RIA) KIT (January 28, 1982)
  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K811213 — T3 (RIA) KIT (May 29, 1981)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

Other clearances for product code CEF

  • K130500 — CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FL (July 26, 2013)
  • K972274 — SPIFE (October 27, 1997)
  • K973316 — REP SPE VIS-60/40 KIT (October 1, 1997)
  • K963018 — BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (June 4, 1997)
  • K964453 — REP 3 FLUR SPE-60 KIT (December 23, 1996)
  • K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (July 17, 1996)
  • K951536 — HYDRAGEL PROTEIN(E) KIT (June 30, 1995)
  • K930317 — REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (August 3, 1993)
  • K922053 — REP SPE PLUS (PONCEAU S) SYSTEM (August 18, 1992)
  • K922024 — REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (July 23, 1992)

FDA data resources