Ulster Scientific, Inc.
Mchenry, IL, US
Ulster Scientific, Inc. appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Ulster Scientific, Inc. between 1980 and 1994. The busiest year on record is 1986, with 4. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1992 | 1 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | FMK | Substantially Equivalent | |
| K920562 | UNISTIK | FMK | Substantially Equivalent | |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | JQW | Substantially Equivalent | |
| K895890 | AUTOPEN | FMF | Substantially Equivalent | |
| K894474 | THE AUTOLET LITE | FMK | Substantially Equivalent | |
| K885340 | AIR DISPLACEMENT PIPETTE | JQW | Substantially Equivalent | |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | LCP | Substantially Equivalent | |
| K871571 | NEUROTIPS(TM) | GXB | Substantially Equivalent | |
| K871076 | WINPETTE | JPH | Substantially Equivalent | |
| K870078 | ACCUPEN(R) | FMF | Substantially Equivalent | |
| K864761 | USI AUTOJECT INSULIN SYRINGE | FMF | Substantially Equivalent | |
| K861243 | NEONATAL UNILET | FMK | Substantially Equivalent | |
| K860899 | DISPETTE II | JPH | Substantially Equivalent | |
| K860284 | DIAMATIC, AUTOMATIC INSULIN INJECTOR | KZH | Substantially Equivalent | |
| K854962 | MICRO-MAT SYSTEM | GKJ | Substantially Equivalent | |
| K851181 | PRECI-JET 50 | KZE | Substantially Equivalent | |
| K842517 | UNILET LANCET | FML | Substantially Equivalent | |
| K831194 | GLUCOKEY | CGA | Substantially Equivalent | |
| K831195 | WESTERGREN DISPETTE FOR ESR | JPH | Substantially Equivalent | |
| K801815 | AUTOLET | JCA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- FMLChair, Blood Donor
- JCADevice, Bleeding Time
- GXBEsthesiometer
- CGAGlucose Oxidase, Glucose
- KZEInjector, Fluid, Non-Electrically Powered
- KZHIntroducer, Syringe Needle
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- GKJSpinner, Slide, Automated
- JQWStation, Pipetting And Diluting, For Clinical Use
- FMFSyringe, Piston
- JPHTest, Erythrocyte Sedimentation Rate
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
