Atlas FDA

MICROSPIN 24

FDA 510(k) clearance K953519 · decided 1995-11-03

Clearance details

K-number
K953519
Device name
MICROSPIN 24
Applicant
Vulcon Technologies
Decision
Substantially Equivalent
Date received
1995-07-27
Decision date
1995-11-03
Days to decision
99 days
Clearance type
Traditional
Product code
GKF
Device class
2
Regulation number
864.5600
Medical specialty
Hematology
Advisory committee
Hematology
Location
Grandview, MO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Vulcon Technologies

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415)Instrumentation Laboratory CO2016-12-14
CRIT-SCAN II MONITOR (K983551)In-Line Diagnostics Corp.1999-05-27
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (K981426)Nova Biomedical Corp.1998-05-12
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (K981425)Nova Biomedical Corp.1998-05-12
STAT PROFILE M ANALYZER (K981427)Nova Biomedical Corp.1998-05-12
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825)Fisher Scientific Co., LLC1992-03-11
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (K915441)Fisher Scientific Co., LLC1992-01-08
NEW COBE SATURATION/HEMATOCRIT MONITOR (K904336)Cobe Laboratories, Inc.1990-12-27
IONOMETER E-HK AND ACCESSORIES (K880373)Smash Ent., Inc.1988-03-17
CHEMPRO 1000(TM) (K870860)Arden Medical Systems, Inc.1987-04-14
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE (K864646)E.I. Dupont DE Nemours & Co., Inc.1987-01-05
MICROHEMATOCRIT CENTRIFUGE (K864039)Plaza Medical, Inc.1986-10-29

Recalls involving this device

No recalls on record reference this clearance.