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PLASMA EXTRACTION SYSTEM

FDA 510(k) clearance K850391 · decided 1985-05-10

Clearance details

K-number
K850391
Device name
PLASMA EXTRACTION SYSTEM
Applicant
Hans J. Brouwers & Assoc.
Decision
Substantially Equivalent
Date received
1985-02-01
Decision date
1985-05-10
Days to decision
98 days
Clearance type
Traditional
Product code
JPI
Device class
2
Regulation number
864.6400
Medical specialty
Hematology
Advisory committee
Hematology
Location
Mount Prospect, 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
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183680)Abbott Point of Care, Inc.2020-02-28
i-STAT Hematocrit test with i-STAT Alinity System (K163342)Abbott Laboratories2017-08-22
CRIT-LINE HEMATOCRIT ALERT (K950942)In-Line Diagnostics Corp.1995-03-14
CRIT-LINE (K924167)Noninvasive Medical Technology Corp.1993-05-07
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (K903698)Statspin Technologies1990-09-17
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (K902028)Norfolk Scientific, Inc.1990-06-20
CHART-TYPE MICRO HEMATOCRIT TUBE READER (K870511)Norfolk Scientific, Inc.1987-03-16
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (K852482)Em Diagnostic Systems, Inc.1985-07-15
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (K852516)Whittaker General Medical1985-07-15
HAEMOFUGE A. BIOFUGE A. & B (K840767)Heraeus-Christ GmbH1984-04-17
COMPUR* M1100 HEMATRCRIT SYSTEM (K831318)Worthington Diagnostic Systems1983-06-08
MICROHEMATOCRIT READER (K830578)Fisher Scientific Co., LLC1983-03-24

Recalls involving this device

No recalls on record reference this clearance.