FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMS HEMATOLOGY MIXER
K Number: K823124
·
Decision Nov 22, 1982
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
4
Applicant Total
22
Review Days
31
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Basic Information
- Device Name
- IMS HEMATOLOGY MIXER
- K Number
- K823124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- October 22, 1982
- Decision Date
- November 22, 1982
- Product Code
- GLE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GLE | Mixer, Blood Tube | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GLE), ordered by most recent decision date.
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|---|---|---|---|
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| K921005 | AUTOLOADER | Apr 29, 1992 | Substantially Equivalent |
| K915457 | PHACO 20/20 SYSTEM I | Feb 24, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |