Electrophoresis Corp. of America: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Electrophoresis Corp. of America” (first 1978, latest 1980), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| CEF | Electrophoretic, Protein Fractionation | 5 | 5 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 3 | 3 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 3 | 3 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 2 | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 | 1 |
| CJH | Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| HYD | Fast Red Salt B | 1 | 1 |
| HZG | Oil Red O | 1 | 1 |
Plus 7 more product codes.
Review panels
- Clinical Chemistry (19)
- Pathology (5)
- Hematology (3)
Most recent Electrophoresis Corp. of America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802396 | GENERAL PROCEDURE AGAROSE FILM | JJN | 1980-11-26 | 55 |
| K792553 | AGAROSE BARBITAL-EDTA BUFFER | JJN | 1980-01-29 | 50 |
| K792551 | ALKALINE PHOSPHATASE REAGENT | CJH | 1980-01-29 | 50 |
| K792548 | ALKALINE PHOSPHATASE MARKER | CIN | 1980-01-29 | 50 |
| K792547 | AGAROSE BARBITAL BUFFER | JJN | 1980-01-29 | 50 |
| K792574 | MOPSO BUFFER | JCC | 1980-01-21 | 39 |
| K792550 | PONCEAU S STAIN SET | KQC | 1980-01-16 | 37 |
| K792552 | AMIDO BLACK 10B STAIN | HZZ | 1979-12-18 | 8 |
| K792549 | FAT RED 7B STAIN SET | HYD | 1979-12-18 | 8 |
| K791657 | LDH ISOENZYME REAGENT | CFE | 1979-09-17 | 27 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electrophoresis Corp. of America.
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.
- Electrophoresis Corp. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electrophoresis Corp. of America?
FDA lists 27 510(k) clearances under the applicant name “Electrophoresis Corp. of America” (first 1978, latest 1980), across 17 product codes in 3 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 Electrophoresis Corp. of America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electrophoresis Corp. of America is 38 days.
Which FDA product codes appear under Electrophoresis Corp. of America?
The most frequent FDA product codes under this applicant name are CEF (Electrophoretic, Protein Fractionation, 5); CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes, 3); JJN (Apparatus, Electrophoresis, For Clinical Use, 3).
Next steps
- See all 27 Electrophoresis Corp. of America clearances with predicates and recalls
- Run predicate analysis for product code CEF, Electrophoresis Corp. of America'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.