FDA product code LIM: Test, Screening, For D Positive Fetal Rbc'S
LIM is the FDA product code for test, screening, for d positive fetal rbc's. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under LIM, from 2 different applicants. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Test, Screening, For D Positive Fetal Rbc'S |
| Device class | Class II |
| Regulation | 21 CFR 864.7455 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LIM clearance
Top LIM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biopool Intl., Inc. | 1 | 1998-04-08 |
| Gamma Biologicals, Inc. | 1 | 1982-05-12 |
Most recent LIM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980314 | Biopool Intl., Inc. | FETAL D TECTION KIT | 1998-04-08 | 71 |
| K820647 | Gamma Biologicals, Inc. | GAMMA FETAL BLEED SCREENING TEST | 1982-05-12 | 64 |
Recalls for LIM devices
openFDA lists no recalls for product code LIM.
Frequently asked questions
What is FDA product code LIM?
LIM is the FDA product code for test, screening, for d positive fetal rbc's. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel.
What device class is LIM?
Class II, regulation 21 CFR 864.7455. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIM?
Across 2 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most LIM clearances?
Biopool Intl., Inc. (1); Gamma Biologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LIM
- Run a recall and safety report across every LIM manufacturer
- Watch product code LIM 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.
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