Biochem International, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Biochem International, Inc.” (first 1977, latest 1994), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 | 6 |
| DQA | Oximeter | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 3 | 3 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CBF | Chamber, Hyperbaric | 1 | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 1 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Biochem International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER | DQA | 1994-04-11 | 825 |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | CBS | 1993-12-03 | 200 |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | DSK | 1993-05-26 | 429 |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | DQA | 1993-01-07 | 366 |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | DXN | 1991-08-22 | 148 |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | CCL | 1991-08-22 | 205 |
| K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR | DXN | 1990-09-04 | 43 |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | CCK | 1990-07-27 | 93 |
| K893877 | BIOCHEM 3100 OXIMETER | DQO | 1989-12-20 | 208 |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | CBQ | 1989-08-31 | 141 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biochem International, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biochem International, Inc. (a text match, not an official crosswalk):
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.
- Biochem Immunosystems (U.S.), Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biochem International, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Biochem International, Inc.” (first 1977, latest 1994), across 15 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 Biochem International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biochem International, Inc. is 83 days.
Which FDA product codes appear under Biochem International, Inc.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 6); DQA (Oximeter, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3).
Next steps
- See all 28 Biochem International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Biochem International, 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.