Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carr-Scarborough Microbiologicals, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
121 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944554 | BRAIN HEART INFUSION AGAR | Carr-Scarborough Microbiologicals, Inc. | 1994-10-04 | 18 | 0 |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | Carr-Scarborough Microbiologicals, Inc. | 1994-08-24 | 121 | 0 |
| K905472 | LAP DISCS | Carr-Scarborough Microbiologicals, Inc. | 1991-02-27 | 83 | 0 |
| K905666 | M. CAT. BUTYRATE DISC | Carr-Scarborough Microbiologicals, Inc. | 1991-02-26 | 70 | 0 |
| K891476 | C. ALBICANS SCREEN | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 | 27 | 0 |
| K882630 | PRO DISCS | Carr-Scarborough Microbiologicals, Inc. | 1989-02-16 | 234 | 0 |
| K882636 | ALN DISCS | Carr-Scarborough Microbiologicals, Inc. | 1989-02-16 | 234 | 0 |
| K863216 | NEIS NZY | Carr-Scarborough Microbiologicals, Inc. | 1986-09-15 | 26 | 0 |
| K860301 | RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE | Carr-Scarborough Microbiologicals, Inc. | 1986-02-06 | 9 | 0 |
| K860302 | PYR DISCS | Carr-Scarborough Microbiologicals, Inc. | 1986-02-05 | 8 | 0 |
| K822930 | CSM CHROMOGENIC B-LACTAMASE DISC | Carr-Scarborough Microbiologicals, Inc. | 1982-11-01 | 28 | 0 |
| K822518 | CSM BETA-LACTAMASE DISC | Carr-Scarborough Microbiologicals, Inc. | 1982-09-21 | 29 | 0 |
| K820346 | CALI-PIPETTE | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 | 24 | 0 |
| K820347 | ACCU-STAPH | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 | 24 | 0 |
| K820345 | CALI-LOOP | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 | 24 | 0 |
| K820149 | PYR BROTH | Carr-Scarborough Microbiologicals, Inc. | 1982-02-05 | 17 | 0 |
| K812668 | AFB STAIN SET | Carr-Scarborough Microbiologicals, Inc. | 1981-09-29 | 8 | 0 |
| K812212 | ACRIDINE ORANGE STAIN | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 | 27 | 0 |
| K812274 | AURAMINE O MYCROBACTERIAL STAIN SET | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 | 19 | 0 |
| K812048 | IDS RAPIDS NH SYSTEMS | Carr-Scarborough Microbiologicals, Inc. | 1981-08-18 | 29 | 0 |
| K812047 | IDS BETA-LACTAMASE DISC | Carr-Scarborough Microbiologicals, Inc. | 1981-08-07 | 18 | 0 |
| K811422 | STREP-ID PLATE | Carr-Scarborough Microbiologicals, Inc. | 1981-06-18 | 29 | 0 |
| K802566 | BETA LACTAMASE REAGENT DISK | Carr-Scarborough Microbiologicals, Inc. | 1980-10-31 | 14 | 0 |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 | 50 | 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