THE CEN-SLIDE(TM) CENTRIFUGE TUBE
FDA 510(k) clearance K891604 · decided 1989-06-16
Clearance details
- K-number
- K891604
- Device name
- THE CEN-SLIDE(TM) CENTRIFUGE TUBE
- Applicant
- Davstar California, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-20
- Decision date
- 1989-06-16
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KEW
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Lawndale, CA, 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 |
|---|---|---|
| MICROSCOPE SLIDES PRECOATED (K890042) | Stat Path | 1989-01-13 |
| MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (K882357) | Stat Path | 1988-06-16 |
| SECTIONING AID KIT (K831065) | Technicon Instruments Corp. | 1983-06-08 |
| FROSTED GLASS SLIDES (K820100) | Stan-Pak Ent. | 1982-03-04 |
| QUANTIMETRIC 2 TEST KIT (K813242) | Kallestad Laboratories, Inc. | 1981-12-02 |
| ABCO ULTRA SLIDE MICROSCOPE SLIDE (K800232) | Abco Dealers, Inc. | 1980-02-21 |
| SLIDE, LAB-TEK COVERED MICRO (K760278) | Miles Laboratories, Inc. | 1976-08-30 |
Recalls involving this device
No recalls on record reference this clearance.