Atlas FDA

COLLOID OSMOMETER 4400

FDA 510(k) clearance K834208 · decided 1984-03-23

Clearance details

K-number
K834208
Device name
COLLOID OSMOMETER 4400
Applicant
Wescor, Inc.
Decision
Substantially Equivalent
Date received
1983-12-05
Decision date
1984-03-23
Days to decision
109 days
Clearance type
Traditional
Product code
JJM
Device class
1
Regulation number
862.2730
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
THE ADVANCED OSMOMETER (3900) (K965036)Advanced Instruments, Inc.1997-02-20
ADVANCED MICRO-OSMOMETER MODEL 3300 (K962056)Advanced Instruments, Inc.1996-07-11
MODEL 3D3 OSMOMETER (K925970)Advanced Instruments, Inc.1993-07-09
OSMOMETER MODEL 2400 (K911092)Advanced Instruments, Inc.1991-05-22
OSMOMETER MODEL 110 (K873642)Advanced Instruments, Inc.1987-10-20
AO-10 AUTOMATED OSMOMETER (K843997)bioMerieux, Inc.1984-10-31
OSMOTIC PRESSURE AUTO & STAT OM-6010 (K842750)Kyoto Diagnostics, Inc.1984-08-17
WESCOR 5500 VAPOR PRESSURE OSMOMETER (K834214)Wescor, Inc.1984-03-30
MICRO-SAMPLE OSMOMETER 3M0 (K832783)Advanced Instruments, Inc.1983-11-28
OSMOMETER MODEL OM-6010 (K811179)Fiske Med Science1981-05-15
OSMOMETER MODEL 3W11 (K790611)Advanced Instruments, Inc.1979-06-15

Recalls involving this device

RecordFirmDate
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), recall (Z-1350-2008)Wescor, Inc2008-03-27
Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each H recall (Z-1351-2008)Wescor, Inc2008-03-27