Norfolk Scientific, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Norfolk Scientific, Inc.” (first 1986, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 25 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 3 | 3 |
| JPI | Device, Hematocrit Measuring | 2 | 2 |
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | 1 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (3)
Most recent Norfolk Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902028 | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | JPI | 1990-06-20 | 47 |
| K890669 | STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE | LBR | 1989-03-08 | 27 |
| K883185 | SAFECRIT PLASTIC MICROHEMATOCRIT TUBES | GHY | 1988-08-18 | 21 |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | JQC | 1988-04-05 | 13 |
| K870511 | CHART-TYPE MICRO HEMATOCRIT TUBE READER | JPI | 1987-03-16 | 39 |
| K864974 | GENERAL PURPOSE CENTRIFUGE | JQC | 1987-01-09 | 21 |
| K860172 | QWIKSPIN (TM) | JQC | 1986-02-11 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Norfolk Scientific, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Norfolk Medical Products, Inc. (20 510(k)s)
- Norfolk Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Norfolk Scientific, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Norfolk Scientific, Inc.” (first 1986, latest 1990), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Norfolk Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Norfolk Scientific, Inc. is 25 days.
Which FDA product codes appear under Norfolk Scientific, Inc.?
The most frequent FDA product codes under this applicant name are JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 3); JPI (Device, Hematocrit Measuring, 2); GHY (Hematocrit, Tube, Rack, Sealer, Holder, 1).
Next steps
- See all 7 Norfolk Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JQC, Norfolk Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.