PHYSIOLOGIC SALINE (0.85%)— 510(k) K761174

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K761174 for PHYSIOLOGIC SALINE (0.85%), Substantially Equivalent on 1977-01-10. Applicant: Bio/Data Corp.. Device class: 1.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code JCE
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1976-12-01
Decision date: 1977-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCE

K842722 — BUFFERED SALINE1984-09-11
K831200 — IMMUNOHEMATOLOGICAL SALINE #971391983-05-09
K801506 — CERTIFIED BLOOD BANK SALINE1980-07-28
K792101 — COUITER/CMS ISOTONIC BLOOD BANK SALINE1979-11-20
K761183 — LYSING AGENT AF1977-01-17

More clearances from Bio/Data Corp.

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K943153 — MICROSAMPLE COAGULATION ANALYZER1995-03-24
K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C1989-06-23
K881150 — KINETIC FIBRINOGEN ASSAY1988-03-28
K873382 — PLATELET EXTRACT REAGENT1987-11-20

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