GRAM STAIN— 510(k) K843050

Substantially Equivalent

Reagent Laboratory, Inc.

FDA 510(k) clearance K843050 for GRAM STAIN, Substantially Equivalent on 1984-09-11. Applicant: Reagent Laboratory, Inc.. Device class: 1.

Clearance details

Applicant: Reagent Laboratory, Inc.
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-08-03
Decision date: 1984-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Reagent Laboratory, Inc.

K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L1986-10-21
K863503 — HEMOLYSE1986-10-03
K863550 — POTASSIUM HYDROXIDE 10% W/V1986-10-02
K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE1986-02-10
K842982 — FORMALIN BUFFERED1984-10-01

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