LACTOSE
FDA 510(k) clearance K833210 · decided 1983-10-27
Clearance details
- K-number
- K833210
- Device name
- LACTOSE
- Applicant
- Acumedia Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-19
- Decision date
- 1983-10-27
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- JSK
- Device class
- 1
- Regulation number
- 866.2450
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATS NAC-PAC SET (K881949) | Alpha-Tec Systems, Inc. | 1988-05-25 |
| ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (K881879) | Alpha-Tec Systems, Inc. | 1988-05-13 |
| HEMOGLOBIN POWDER (K881566) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (K861997) | Hazleton Research Products, Inc. | 1986-06-10 |
| GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824) | Flow Laboratories, Inc. | 1986-05-20 |
| GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823) | Flow Laboratories, Inc. | 1986-05-20 |
| PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791) | Flow Laboratories, Inc. | 1986-05-20 |
| KWI (TM) G-CO/TWO (K855172) | Micro-Bio-Logics | 1986-02-20 |
| ABBOTT CATION SUPPLEMENT SOLUTION (K853546) | Abbott Laboratories | 1985-09-06 |
| SUPLEX & SUPLEX DILUENT (K850302) | Pro-Lab, Inc. | 1985-03-22 |
| C.N.V.T. (K850299) | Pro-Lab, Inc. | 1985-03-20 |
| CAMPYLOBACTER SUPPLEMENT-BLASER/WANG (K850307) | Pro-Lab, Inc. | 1985-03-20 |
Recalls involving this device
No recalls on record reference this clearance.