FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIR DISPLACEMENT PIPETTE
K Number: K885340
·
Decision Feb 14, 1989
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
20
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AIR DISPLACEMENT PIPETTE
- K Number
- K885340
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- December 28, 1988
- Decision Date
- February 14, 1989
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQW), ordered by most recent decision date.
BD VIPER INSTRUMENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2700 SAMPLE MANAGER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MASTERCAP AM 5.0/MASTERCAP RM 5.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MINI SAMPLER PROCESSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Ulster Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Jun 22, 1994 | Substantially Equivalent |
| K920562 | UNISTIK | Mar 27, 1992 | Substantially Equivalent |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | Jul 19, 1990 | Substantially Equivalent |
| K895890 | AUTOPEN | Feb 16, 1990 | Substantially Equivalent |
| K894474 | THE AUTOLET LITE | Aug 18, 1989 | Substantially Equivalent |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Feb 17, 1988 | Substantially Equivalent |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent |
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Dec 16, 1986 | Substantially Equivalent |