International Enzymes, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “International Enzymes, Inc.” (first 1994, latest 2001), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Immunology (2)
Most recent International Enzymes, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 | JJY | 2001-05-18 | 31 |
| K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | JJX | 1996-08-20 | 12 |
| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | DCF | 1995-09-15 | 31 |
| K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | DCK | 1995-09-15 | 31 |
| K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM | JJY | 1995-06-01 | 100 |
| K944513 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E | JJY | 1994-12-02 | 78 |
| K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E | JJY | 1994-12-02 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named International Enzymes, 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.
- International Technidyne Corp. (48 510(k)s)
- International Imaging Electronics (19 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Enzymes, Inc.?
FDA lists 7 510(k) clearances under the applicant name “International Enzymes, Inc.” (first 1994, latest 2001), 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 International Enzymes, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Enzymes, Inc. is 31 days.
Which FDA product codes appear under International Enzymes, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); DCF (Albumin, Antigen, Antiserum, Control, 1); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1).
Next steps
- See all 7 International Enzymes, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, International Enzymes, 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.