Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Controls, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
346 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUC | Clinical Controls, Inc. | 1996-11-22 | 25 | 0 |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | Clinical Controls, Inc. | 1996-07-05 | 11 | 0 |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | 1996-04-24 | 132 | 0 |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | Clinical Controls, Inc. | 1996-04-24 | 132 | 0 |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Clinical Controls, Inc. | 1995-08-24 | 244 | 0 |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | Clinical Controls, Inc. | 1995-05-02 | 529 | 0 |
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | Clinical Controls, Inc. | 1995-02-10 | 49 | 0 |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | 60 | 0 |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | 60 | 0 |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | 60 | 0 |
| K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL | Clinical Controls, Inc. | 1995-02-08 | 54 | 0 |
| K946143 | CHEMSPEX(TM) AMMONIA CONTROL | Clinical Controls, Inc. | 1995-02-03 | 49 | 0 |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | Clinical Controls, Inc. | 1995-01-24 | 39 | 0 |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | Clinical Controls, Inc. | 1995-01-24 | 39 | 0 |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | Clinical Controls, Inc. | 1994-11-04 | 29 | 0 |
| K935599 | HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 | Clinical Controls, Inc. | 1994-10-31 | 346 | 0 |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | 1994-09-08 | 342 | 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