Allied Instrumentation Laboratory: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Allied Instrumentation Laboratory” (first 1985, latest 1986), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
Review panels
Most recent Allied Instrumentation Laboratory 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861901 | MULTI-4 CO-OXIMETER CONTROL | JJY | 1986-06-17 | 32 |
| K860365 | PHENOBARBITAL TEST SYSTEM | DLZ | 1986-03-17 | 42 |
| K860286 | IL TEST PHENYTOIN | DIP | 1986-03-05 | 36 |
| K853858 | IL TEST THEOPHYLLINE ASSAY | KLS | 1985-10-15 | 29 |
| K852676 | IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS | CHL | 1985-07-22 | 28 |
| K851933 | CLINICAL CHEMISTRY ANALYTICAL SYSTEM | JJF | 1985-06-10 | 39 |
| K850748 | I-L TEST, DIRECT BILIRUBIN SET | CIG | 1985-04-03 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Allied Instrumentation Laboratory.
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.
- Allied Healthcare Products, Inc. (26 510(k)s)
- Allied Associates, Inc. (9 510(k)s)
- Allied Biomedical Corp. (9 510(k)s)
- Allied Rubber Industries Sdn. Bhd. (2 510(k)s)
- Allied Signal, Inc. (2 510(k)s)
- Allied Advanced Technologies (Aat) (1 510(k)s)
- Allied Dental Solutions (1 510(k)s)
- Allied Fisher Scientific (1 510(k)s)
- Allied Hill Enterprises, Ltd. (1 510(k)s)
- Allied Medical Technologies, Inc. (1 510(k)s)
- Allied Photo Products Co., Inc. (1 510(k)s)
- Allied Systems Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Allied Instrumentation Laboratory?
FDA lists 7 510(k) clearances under the applicant name “Allied Instrumentation Laboratory” (first 1985, latest 1986), across 7 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 Allied Instrumentation Laboratory?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allied Instrumentation Laboratory is 36 days.
Which FDA product codes appear under Allied Instrumentation Laboratory?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 1); CIG (Diazo Colorimetry, Bilirubin, 1); DIP (Enzyme Immunoassay, Diphenylhydantoin, 1).
Next steps
- See all 7 Allied Instrumentation Laboratory clearances with predicates and recalls
- Run predicate analysis for product code CHL, Allied Instrumentation Laboratory'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.