Ncs Diagnostics, Inc.
Mchenry, IL, US
Ncs Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Ncs Diagnostics, Inc. between 1984 and 1994. The busiest year on record is 1986, with 5. The most recent is 1994, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 3 |
| 1988 | 2 |
| 1994 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | Substantially Equivalent | |
| K943498 | KULTSURE STARSWAB (M210), MODIFICATION | JSM | Substantially Equivalent | |
| K882811 | STREPSLIDE | GTY | Substantially Equivalent | |
| K881209 | ASO SLIDE TEST | GTQ | Substantially Equivalent | |
| K874019 | STAPHSLIDE | JWX | Substantially Equivalent | |
| K871404 | KULTSURE | JSM | Substantially Equivalent | |
| K870231 | KULTSURE | LIO | Substantially Equivalent | |
| K860178 | KULTSURE (CULTURE TRANSPORT) | JSM | Substantially Equivalent | |
| K860655 | KULTSURE (CATALOGUE NO. M200) | LIO | Substantially Equivalent | |
| K860658 | KULTSURE (CATALOGUE NO. M250) | JSM | Substantially Equivalent | |
| K860657 | KULTSURE (CATALOGUE NO. M240) | JSM | Substantially Equivalent | |
| K860656 | KULTSURE (CATALOGUE NO. M210) | JSM | Substantially Equivalent | |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | GMP | Substantially Equivalent | |
| K851506 | SERUM TRANSPORT VIALS, T25/SC, TZ10/SC | JKA | Substantially Equivalent | |
| K841146 | NCS RA LATEX TEST | DHR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTYAntigens, All Groups, Streptococcus Spp.
- GMPAntisera, Control For Nontreponemal Tests
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JSMCulture Media, Non-Propagating Transport
- LIODevice, Specimen Collection
- JWXKit, Screening, Staphylococcus Aureus
- DHRSystem, Test, Rheumatoid Factor
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain