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510(k) K933128

SYNELISA PROGESTERONE by Elias U.S.A., Inc. — Product Code JLS

K933128 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "SYNELISA PROGESTERONE". The FDA issued a decision of Substantially Equivalent on November 5, 1993. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1993
Date Received
June 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

Other clearances by Elias U.S.A., Inc.

  • K964385 — ELIAS ANA-HEP-2 (March 6, 1997)
  • K963291 — VARELISA ANA (4) PROFILE (September 30, 1996)
  • K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES (August 30, 1996)
  • K953587 — VARELISA MPO-ANCA (January 26, 1996)
  • K953586 — VARELISA PR3-ANCA (January 26, 1996)
  • K951187 — VARELISA CARDIOLIPIN ABS SCREEN (October 2, 1995)
  • K951205 — VARELISA ANA PROFILE (April 17, 1995)
  • K951186 — VARELISA ANA-4 SCREEN (April 17, 1995)
  • K951206 — VARELISA PARIETAL CELL ANTIBODIES (April 17, 1995)
  • K944334 — VARELISA COMBINED DNA ANTIBODIES EIA (April 17, 1995)

Other clearances for product code JLS

  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K973898 — PROGESTERONE ELISA (November 13, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)
  • K964841 — ELECSYS PROGESTERONE ASSAY (March 24, 1997)
  • K965084 — VIDAS PROESTERONE (PRG) (30 409) (January 9, 1997)
  • K955025 — AXSYM PROGESTERONE (March 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (February 5, 1996)
  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)

FDA data resources