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510(k) K863188

HPL RIA KIT by Biotecx Laboratories, Inc. — Product Code JMX

K863188 is an FDA 510(k) premarket notification submitted by Biotecx Laboratories, Inc. for the device "HPL RIA KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code JMX (Ninhydrin, Nitrogen (Amino-Nitrogen)), a Class I device regulated under 21 CFR 862.1515. Biotecx Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ninhydrin, Nitrogen (Amino-Nitrogen)
Device Class
Class I
Regulation Number
862.1515
Review Panel
CH
Submission Type

Other clearances by Biotecx Laboratories, Inc.

  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K895407 — CORTISOL CLASP-BEAD EIA KIT (October 19, 1989)
  • K893620 — T3 CLASP-BEAD EIA KIT (August 11, 1989)
  • K892853 — T4 CLASP-BEAD EIA KIT (May 22, 1989)
  • K883765 — TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (October 31, 1988)
  • K871211 — PROGESTERONE CLASP RADIOIMMUNOASSAY KIT (April 13, 1987)
  • K854876 — ALDOSTERONE DIRECT RIA KIT (March 17, 1986)
  • K851540 — ESTRADIOL DIRECT RIA KIT (June 6, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)

Other clearances for product code JMX

  • K780847 — NINHYDRIN REAGENT KIT (June 13, 1978)

FDA data resources