FDA product code CFL: Radioimmunoassay, Human Growth Hormone
CFL is the FDA product code for radioimmunoassay, human growth hormone. It is a Class I device, regulated under 21 CFR 862.1370 and reviewed by the Clinical Chemistry panel. FDA has cleared 36 510(k) submissions under CFL, from 20 different applicants. The average 510(k) review took 90 days (median 42). FDA has posted 5 recalls for CFL devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Human Growth Hormone |
| Device class | Class I |
| Regulation | 21 CFR 862.1370 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFL clearance
Top CFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 10 | 1997-05-12 |
| Nichols Institute Diagnostics | 4 | 1996-07-08 |
| Diagnostic Products Corp. | 2 | 1996-02-16 |
| Nichols Institute | 2 | 1995-07-03 |
| Medix Biotech, Inc. | 2 | 1992-03-04 |
15 more applicants have CFL clearances. See the full list in Caduvo.
Most recent CFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972761 | Sealite Sciences, Inc. | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | 1997-09-25 | 63 |
| K971353 | Diagnostic Systems Laboratories, Inc. | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | 1997-05-12 | 31 |
| K970701 | Diagnostic Systems Laboratories, Inc. | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | 1997-04-02 | 35 |
| K962758 | Diagnostic Systems Laboratories, Inc. | DSL 9100 IGF-II IRMA | 1996-08-30 | 45 |
| K961678 | Nichols Institute Diagnostics | HUMAN GROWTH HORMONE IMMUNOASSAY KIT | 1996-07-08 | 68 |
Recalls for CFL devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code CFL?
CFL is the FDA product code for radioimmunoassay, human growth hormone. It is a Class I device, regulated under 21 CFR 862.1370 and reviewed by the Clinical Chemistry panel.
What device class is CFL?
Class I, regulation 21 CFR 862.1370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFL?
Across 36 cleared submissions the average was 90 days from receipt to decision (median 42).
Which companies have the most CFL clearances?
Diagnostic Systems Laboratories, Inc. (10); Nichols Institute Diagnostics (4); Diagnostic Products Corp. (2); Nichols Institute (2); Medix Biotech, Inc. (2).
Have CFL devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code CFL
- Run a recall and safety report across every CFL manufacturer
- Watch product code CFL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times