GESTE FOLLOW KIT DETERM. OF HPL— 510(k) K802454

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K802454 for GESTE FOLLOW KIT DETERM. OF HPL, Substantially Equivalent on 1980-11-12. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code JMF
Device class: Class 2
Regulation: 21 CFR 862.1585
Advisory panel: Clinical Chemistry
Date received: 1980-10-08
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMF

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K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN1984-04-04
K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY1982-12-28
K823201 — HUMAN PLACENTAL LACTOGEN KIT1982-11-29
K811370 — NATAL-TEC HPL1981-05-29

More clearances from Syn-Kit, Inc.

K861098 — SEROIDEN STREPTO KIT 'EIKEN'1986-08-12
K861631 — SLIDE CULTURE U 'EIKEN'1986-06-10
K854819 — CPR SLIDE EIKEN1986-02-26
K854820 — RA 80 EIKEN1986-01-17
K853276 — ASO SLIDE EIKEN1985-08-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.