IMS HEMATOLOGY MIXER
FDA 510(k) clearance K823124 · decided 1982-11-22
Clearance details
- K-number
- K823124
- Device name
- IMS HEMATOLOGY MIXER
- Applicant
- Innovative Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-22
- Decision date
- 1982-11-22
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GLE
- Device class
- 1
- Regulation number
- 862.2050
- 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.
| Record | Firm | Date |
|---|---|---|
| CORTEX DOUBLE HELIX SAMPLER (K800003) | Cortex Research Corp. | 1980-02-01 |
| DISC-PAK ROTATOR (K780544) | Techhnilab Instruments, Inc. | 1978-04-24 |
| SPECI-MIX (K771617) | Thermolyne Corp. | 1977-09-02 |
| PLATELET AGITATOR (K770830) | Helmer Labs, Inc. | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S005) | Innovative Medical Systems, Inc. | 2002-06-12 |
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S004) | Innovative Medical Systems, Inc. | 2001-08-15 |
| SHARP(X)TM NEEDLE DESTRUCTION UNIT (P980015/S003) | Innovative Medical Systems, Inc. | 1999-09-17 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S002) | Innovative Medical Systems, Inc. | 1999-03-19 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S001) | Innovative Medical Systems, Inc. | 1998-12-14 |
| SHARPX (P980015) | Innovative Medical Systems, Inc. | 1998-08-06 |