Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scientific Device Laboratory, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
91 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935316 | PARASAFE(R) FIXATIVE | Scientific Device Laboratory, Inc. | 1994-02-17 | 107 | 0 |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1993-01-15 | 109 | 0 |
| K911059 | TURBIDOMETRIC STANDARD | Scientific Device Laboratory, Inc. | 1991-06-10 | 91 | 0 |
| K895848 | PRESSURE STEAM STERILIZERS | Scientific Device Laboratory, Inc. | 1989-12-11 | 69 | 0 |
| K890718 | GRAM STAIN CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 | 31 | 1 |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 | 35 | 0 |
| K884069 | SNAP N' STAIN IODINE STAIN | Scientific Device Laboratory, Inc. | 1988-10-25 | 28 | 0 |
| K884011 | SNAP N' STAIN IRON STAIN | Scientific Device Laboratory, Inc. | 1988-10-06 | 14 | 0 |
| K883052 | METHENO-STAIN KIT | Scientific Device Laboratory, Inc. | 1988-08-30 | 42 | 0 |
| K881598 | SDL TRICHROME STAIN | Scientific Device Laboratory, Inc. | 1988-05-04 | 21 | 0 |
| K840506 | HAEMOPHILUS INFLUENZAE TYPE B | Scientific Device Laboratory, Inc. | 1984-04-04 | 58 | 0 |
| K840503 | SDL LISTERIA MONOCYTOGENES CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840509 | NEISSERIA MENINGITIDIS GR. B | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840505 | SDL NEISSERIA MENNINGITIDIS GR. X | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840504 | SDL NEISSERIA MENINGITIDES GR. 2 | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840507 | NEISSERIA MENINGITIDIS GR. Y | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840510 | NEISSERIA MENINGITIDIS GR. A | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840511 | STREPTOCOCCUS GR. D | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840514 | NEISSERIA MENINGITIDIS CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840512 | STREPTOCOCCUS PNEUMONIAE CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840508 | NEISSERIA MENINGITIDIS GR. C | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840513 | STREPTOCOCCUS GR. B CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840515 | ACID FAST BACILLI STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K840517 | PROTOZOA STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K840516 | METACHROMATIC GRANULE STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 | 32 | 0 |
| K840518 | SABOURAUD AGAR SLANTS | Scientific Device Laboratory, Inc. | 1984-03-02 | 25 | 0 |
| K840519 | DTM AGAR | Scientific Device Laboratory, Inc. | 1984-02-27 | 21 | 0 |
| K840520 | MYCOLOGICAL SELECTIVE MEDIUM | Scientific Device Laboratory, Inc. | 1984-02-27 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda